DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.)

FDA Device Registration & Listing · TORONTO Ontario, CA · Registration 9680091

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9680091
FEI Number
3002806830
Entity Name
DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.)
City/State/Country
TORONTO Ontario, CA
Establishment Address
104 SHORTING RD., TORONTO Ontario M1S 3S4, CA
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GENTELL (Owner Number: 10026501)
Owner / Operator Contact Address
180 Rittenhouse Circle, Bristol, PA 19007, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K894205
PMA Number
N/A

All Registered Proprietary Names

DKC20062 Petrolatum Gauze Non-Adhering Dressing Size 3" x 36" DKC77030 Petrolatum Gauze Non-Adhering Dressing Size 1" x 8" DKC20068 Xeroform Petrolatum Dressing Size 5" x 9" DKC20065 Petrolatum Gauze Non-Adhering Dressing Size 6" x 36" MCK2243R McKesson Xeroform Roll Petrolatum Dressings 4 inch x 3 yards (10.2 cm x 2.7 m) DKC20059 Petrolatum Gauze Non-Adhering Dressing Size 3" x 18" DKC77165 Xeroform Petrolatum Dressing Size 4" x 4" MCK2201 McKesson Xeroform Sheet Petrolatum Dressings 1”x 8” (12.5 cm x 20.3 cm) (50s) DKC77034 Xeroform Petrolatum Dressing Size 1" x 8" MCK2207 McKesson Xeroform Sheet Petrolatum Dressings 5”x 9” (12.7 cm x 22.9 cm) (50s) DKC20049 Petrolatum Gauze Non-Adhering Dressing Size 1/2" x 72" MCK2202 McKesson Xeroform Sheet Petrolatum Dressings 2”x 2” (5.1 cm x 5.1 cm) (25s) DKC20056 Petrolatum Gauze Non-Adhering Dressing Size 3" x 9" MCK2206 McKesson Xeroform Sheet Petrolatum Dressings 4”x 4” (10.2 cm x 10.2 cm) (25s) DKC77164 Xeroform Petrolatum Dressing Size 2" x 2" DKC20053 Petrolatum Gauze Non-Adhering Dressing Size 1" x 36" 61-20056 Petrolatum Gauze Non-Adhering Dressing Size 3" x 9" Derma Wound Kit SPD-03 Dermagran Hydrophylic Ointment 3oz Tube SPD-20 Dermagran B Hydrophilic Wound Dressings 2" x 2" SPD-24 Dermagran B Hydrophilic Wound Dressings 4" x 8" SPD-21 Dermagran B Hydrophilic Wound Dressings 4" x 4" TCC-EZ Saw 61-77042 Oil Emulsion Dressing 3"X8" 61-77041 Oil Emulsion Dressing 3"X3" DKC77043 Shur Oil Emulsion Non-Adhering Dressing Size 3" x 16" DKC77041 Shur Oil Emulsion Non-Adhering Dressing Size 3" x 3" DKC77044 Shur Oil Emulsion Non-Adhering Dressing Size 3" x 8", 3's DKC77042 Shur Oil Emulsion Non-Adhering Dressing Size 3" x 8" BSK-SPC0003702AB-BLUESKY OIL EMULSION NON-ADH GAUZE 3"X 8" BSK-SPC0003701AB- BLUESKY OIL EMULSION NON-ADH GAUZE 3"X 3" CAH8884421600 Cardinal Vaseline 1/2" x 72" with Overwrap CAH8884425600 Cardinal Vaseline 3" x 36" with Overwrap CAH8884426600 Cardinal Vaseline 6"X36" with Overwrap CAH8884424600 Cardinal Vaseline 3" x 18"  with Overwrap CAH8884412600 Cardinal Vaseline 1"X 36" CAH8884416600 Cardinal Vaseline 6"X36" CAH8884417601 Cardinal Vaseline 1"X 8" CAH8884422600 Cardinal Vaseline 1"X 36" with Overwrap CAH8884414600 Cardinal Vaseline 3" x 18" CAH8884423600 Cardinal Vaseline 3" x 9"  with Overwrap CAH8884413605 Cardinal Vaseline 3" x 9" CAH8884415600 Cardinal Vaseline 3" x 36" Burnfree 1/8 Oz TCC2-FCT04 TCC-EZ MEDE KAST 4" ROLL FIBERGLASS CAST TAPE, 4" X 4YDS TCC2-1126 TCC-EZ X-LARGE CHARCOT BOOT...PK:1/CS TCC2-3000 TCC-EZ CASTING SYSTEM 3" CASE OF 10 WITH 2 REGULAR BOOTS. TCC2-4214 TCC-EZ CASTING SYSTEM 4" CASE OF 10 WITH 2 LARGE BOOTS TCC2-3001 TCC-EZ CASTING SYSTEM 3" CASE OF 10 WITHOUT BOOTS...PK:10/CS TCC2-5051 TCC-EZ CASTING SYSTEM CASE OF 5-3" AND 5-4" WITH NO BOOTS TCC2-4001 TCC-EZ CASTING SYSTEM 4" CASE OF 10 WITHOUT BOOTS...PK:10/CS TCC2-1131 TCC-EZ TRANSMET BOOT TCC2-4014 TCC-EZ CASTING SYSTEM 4" CASE OF 10 WITH 1 LARGE BOOT...PK:1 TCC2-1124 TCC-EZ X-LARGE BOOT...PK:1/CS TCC2-1114 TCC-EZ LARGE BOOT...PK:1/CS TCC2-4051 TCC-EZ CASTING SYSTEM 4" CASE OF 5 WITHOUT BOOT...PK: 5/CS TCC2-4000 TCC-EZ CASTING SYSTEM 4" CASE OF 10 WITH 2 REGULAR BOOTS. TCC2-3051 TCC-EZ CASTING SYSTEM 3" CASE OF 5 WITHOUT BOOT...PK:5/CS TCC2-4005 TCC-EZ CASTING SYSTEM 4" CASE OF 5 WITH 1 REGULAR BOOT TCC2-4002 TCC-EZ CASTING SYSTEM 4" SINGLE KIT...PK:1/CS TCC2ULTR MEDE KAST CASTING SYSTEM...PK:10/CASE TCC2GSII TCC CAST MEDE-KAST - CASE OF 10'S...PK:10/CASE TCC2-3005 TCC-EZ CASTING SYSTEM 3" CASE OF 5 WITH 1 REGULAR BOOT. TCC2-1116 TCC-EZ LARGE CHARCOT BOOT...PK:1/CS TCC2-1100 TCC-EZ REGULAR BOOT...PK:1/CS TCC2-FCT03 TCC-EZ MEDE KAST 3" ROLL FIBERGLASS CAST TAPE, 3" X 4YDS TCC2-3214 TCC-EZ CASTING SYSTEM 3" CASE OF 10 WITH 2 LARGE BOOTS. TCC2MDKK TCC CAST MEDE-KAST - CASE OF 10'S...PK:10/CASE TCC2-3002 TCC-EZ CASTING SYSTEM 3" SINGLE KIT...PK: 1/CS GEN-13220 Gentell Calcium Alginate Ag 2" x 2" DUP88548 Algicell Ag Calcium Alginate Dressing 4" x 8" DUP88512 Algicell Ag Calcium Alginate Dressing 0.75" x 12" CVS88522-4 CVS ANTIMICROBIAL SILVER 2" X 2" RIT885224 RITE AID ANTIBACTERIAL SILVER ALGINATE DRESSING 2"X 2" DUP88544 Algicell Ag Calcium Alginate Dressing 4.25" x 4.25" DUP88545 Algicell Ag Calcium Alginate Dressing 4" x 5" DUP88582 Algicell Ag Calcium Alginate Dressing 8 x 12" GEN 13420 Gentell Calcium Alginate Ag 4" x 4" GEN-13620 Gentell Calcium Alginate Ag 6" x 6" DUP88522 Algicell Ag Calcium Alginate Dressing 2" x 2" DUP87810 Dupad Abdominal Pad 8" x 10" Sterile DUP97159 Dupad Abdominal Pad 5" x 9" Non -Sterile DUP97188 Dupad Abdominal Pad 8" x 7-1/2" Non-Sterile DUP97110 Dupad Abdominal Pad 8" x 10" Non-Sterile DUP87059 Dupad Abdominal Pad 5" x 9" Sterile DUP87088 Dupad Abdominal Pad 8" x 7-1/2" Sterile Hydrogel Silver GEN 11230 Hydrogel Ag Wound 3oz tube 59246 Pak-Its Gauze IodoformPacking Strips Size 1/2" x 5 yd 59346 Pak-Its Gauze Iodoform Packing Strips Size 1" x 5 yd 59145 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 1/4" x 5 yd 59445 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 2" x 5 yd 59146 Pak-Its Gauze Iodoform Packing Strips Size 1/4" x 5 yd 59345 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 1" x 5 yd 59245 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 1/2" x 5 yd CS50 - Cath-Strip Reclosable Catheter Fastener 95X102 mm Aquasite Hydrogel Would Dressing HC1515 Hydro Fiber Dressing 15x15cm / 6x6in GEN-15480 Bordered Gauze 4" x 8" GEN-19690 Sacral Silicone Superabsorbent Dressing DUP86266-9 - Xtrasorb Foam Adhesive DUP86144-9 - Xtrasorb Foam Non-Adhesive GEN-14700 Gentell Bordered Silicone Foam Sacral ; 9” x 9” GEN-14544 Gentell Waterproof Foam Dressing(Non-Bordered);4"x 4" DUP89533 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 3" X 3" DUP86144 Xtrasorb Super Absorbent Dressing Foam Non-Adhesive 4" X 4.75" GEN-14540 Gentell Split Drain Foam Dressing(Non-Bordered);4” x 5” GEN-15440 Gentell Split Drain Bordered Gauze; 4" GEN-14410 Gentell Circular Split Drain Foam Dressing; 4" GEN-15410 Gentell Bordered Gauze; 4" x 4'' GEN-13480 Gentell Calcium Alginate Dressing; 4" x 8" GEN-19420 Gentell Super Absorbent Adherent Dressing; 2" x 2" DUP86244 Xtrasorb Super Absorbent Dressing Foam Adhesive 4.5" X 4.5" GEN-13200 Gentell Calcium Alginate Dressing; 2" x 2" GEN-19640 Gentell Silicone Super Absorbent Dressing; 4"x4" GEN-19340 Gentell Super Absobent Dressing; 4"x 4" GEN-14400 Gentell Bordered Foam; 4" x 4" DUP89569 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 6" X 9" DUP88112 Algicell Calcium Alginate Dressing 3/4" x 12" GEN-19460 Gentell Superabsorbent Adherent Dressing 6" x 6" DUP86244-9 - Xtrasorb Foam Adhesive GEN-13040 Gentell CMC Fiber Dressing; 4" x 4" DUP86266 Xtrasorb Super Absorbent Dressing Foam Adhesive 6" X 6" DUP86188-9 - Xtrasorb Foam Non-Adhesive DUP88022 Algicell Calcium Alginate Dressing 2" x 2" DUP86233-9 - Xtrasorb Foam Adhesive DUP88100 Algicell Calcium Alginate Dressing 3/4" X 36" CFT2020 Polyurethane Foam Tracheostomy Dressing 20x20cm / 8x8in GEN-15610 Gentell Bordered Gauze; 6" x 6" GEN-15414 Gentell Silicone Bordered Gauze; 4"x4" GEN-14744 Gentell Bordered Silicone Foam; 4"x 4" GEN-19680 Gentell Silicone Super Absorbent Dressing; 8"x8" DUP86122 Xtrasorb Super Absorbent Dressing Foam Non-Adhesive 2" X 2" GEN13060 Gelling Fiber Dressing 6”x6” (15cmx15cm) DUP86388 Xtrasorb Super Absorbent Dressing HCS Non Adhesive 8" X 8" GEN13020 Gelling Fiber Dressing 2”x2” (5cmx5cm) GEN-14522 Gentell Waterproof Foam Dressing(Non-Bordered);2"x 2" A 0505 Calcium Alginate Dressing 5x5cm / 2x2in HC0505 Hydro Fiber Dressing 5x5cm / 2x2in GEN-19320 Gentell Super Absobent Dressing; 2"x 2" GEN-19350 Gentell Super Absobent Dressing; 5"x 5" CFT1010 Polyurethane Foam Tracheostomy Dressing 10x10cm / 4x4in GEN-13120 Gentell Calcium Alginate Dressing; 12" Rope CF1010 Polyurethane Foam Dressing 10x10cm / 4x4in DUP88048 Algicell Calcium Alginate Dressing 4" x 8" GEN-12400 Comfortell Composite Dressing; 4" x 4" GEN-11260 Gentell Acute Surgical Incisions Dressing DUP86433 Xtrasorb Super Absorbent Dressing HCS Adhesive 3" X 3" GEN-13020 Gentell CMC Fiber Dressing; 2" x 2" GEN-14766 Gentell Bordered Silicone Foam; 6"x 6" DUP86233 Xtrasorb Super Absorbent Dressing Foam Adhesive 3.2" X 3.2" GEN-19480 Gentell Super Absorbent Adherent Dressing; 8" x 8" GEN-13010 Gentell Calcium Alginate Dressing; 10" x 10" DUP86344 Xtrasorb Super Absorbent Dressing HCS Non Adhesive 4.5" X 4.5" DUP88044 Algicell Calcium Alginate Dressing 4" x 4" GEN-14600 Gentell Bordered Foam; 6" x 6" GEN-14777 Gentell Bordered Silicone Foam; 7"x 7" GEN-13500 Gentell Calcium Alginate Dressing; 4" x 4" GEN-13700 Gentell Calcium Alginate Dressing; 6" x 6" 61-89545 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 4" X 5" DUP86322 Xtrasorb Super Absorbent Dressing HCS Non Adhesive 2.3" X 2.3" GEN-12600 Comfortell Composite Dressing; 6" x 6" GEN-19380 Gentell Super Absobent Dressing; 8"x 8" DUP86188 Xtrasorb Super Absorbent Dressing Foam Non-Adhesive 8" X 8" GEN13040 Gelling Fiber Dressing 4”x4” (10cmx10cm) Lansinoh C section Hydrogel Pads DUP86122-9 - Xtrasorb Foam Non-Adhesive GEN-13060 Gentell CMC Fiber Dressing; 6" x 6" A 1010 Calcium Alginate Dressing 10x10cm / 4x4in GEN-19450 Gentell Super Absorbent Adherent Dressing; 5" x 5" GEN-14799 Gentell Bordered Silicone Foam; 9"x 9" DUP89545 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 4" X 5" DUP86466 Xtrasorb Super Absorbent Dressing HCS Adhesive 6" X 6" GEN-15616 Gentell Silicone Bordered Gauze; 6"x6" GEN-14588 Gentell Waterproof Foam Dressing(Non-Bordered); 8"x 8" GEN-14555 Gentell Waterproof Foam Dressing(Non-Bordered); 5"x 5" GEN-15810 Gentell Bordered Gauze; 8" x 8" GEN-15818 Gentell Silicone Bordered Gauze; 8"x8" GEN-19660 Gentell Silicone Super Absorbent Dressing; 6"x6" DUP89544 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 4" X 4" A 1020 Calcium Alginate Dressing 10x20cm / 4x8in CF060607 Polyurethane Foam Dressing 6x6cm / 3x3in 61-89569 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 6" X 9" HC1010 Hydro Fiber Dressing 10x10cm / 4x4in A 0230 Calcium Alginate Dressing 2x30cm / .8x12in MM0121 Gentell Fiber Dressing 5” x 5” (10cm x 12.5cm) (formerly MEDSAF 5” x 5” (10cm x 12.5cm)) A 1515 Calcium Alginate Dressing 15x15cm / 6x6in CF2020 Polyurethane Foam Dressing 20x20cm / 8x8in Duflex Conforming Bandage Wound measuring kit gel-e Flex+ gel OTC Zinc Wound Wash First Aid Cleanser WC-04 DermaGran Wound Cleanser with Zinc 4 oz 69201 Primaderm Dermal Wound Cleanser 16 fl oz Spray Bottle Non Sterile 69101 Primaderm Dermal Wound Cleanser 4.15oz 69202 Primaderm Dermal Wound Cleanser 4.15oz Non Sterile BSN7261002- Cutimed Hydrogel 25 grams tube w/applicator GEN-19100 Gentell Petrolatum Gauze Dressing; 3"x9" GEN-10200 Dermatell Hydrocolloid Dressing with Border; 4"x4" GEN-19000 Gentell Oil Emulsion Dressing; 3"x3" GEN-16450 Gentell MVP Transparent Dressing; 4"x4.75" GEN-10100 Dermatell Non-Bordered Hydrocolloid Dressing; 4"x4" Gentell Honey Gauze Dressing; 4"x4" GEN-11100 Dermatell Hydrocolloid Dressing Sacral; 6"x7" GEN-10400 Dermatell Hydrocolloid Dressing with Border; 6"x6" BSN7261000- Cutimed Hydrogel 8 grams tube w/applicator BSN7253901 CUTICELL OIL EMULSION DRESSING 3"X 3" STERILE 1'S, 50/BOX H315 Hydrocolloid Dressing Extra Thin 15x20cm / 6x8in BSN7253902 -CUTICELL OIL EMULSION DRESS, 3" X 8" , 10/BOX BSN7253900 -CUTICELL OIL EMULSION DRESS, 3" X 3" , 10/BOX BSN7261003- Cutimed Hydrogel 15 grams tube Cuticell Oil Emulsion Dressing H115 Hydrocolloid Dressing Regular 15x20cm / 6x8in H320 Hydrocolloid Dressing Extra Thin 20x20cm / 8x8in BSN7253903-CUTICELL OIL EMULSION DRESSING 3"X 8", 50/BOX H213 Hydrocolloid Dressing Border 15x18cm / 6x7in H218 Hydrocolloid Dressing Border 20x21cm / 8x8in H120 Hydrocolloid Dressing Regular 20x20cm / 8x8in H112 Hydrocolloid Dressing Regular 15x15cm / 6x6in BSN7261001- Cutimed Hydrogel 15 grams tube w/applicator BSN7253904-CUTICELL OIL EMULSION DRESSING 8"X 16" STERILE, 25/BOX H312 Hydrocolloid Dressing Extra Thin 15x15cm / 6x6in H310 Hydrocolloid Dressing Extra Thin 10x10cm / 4x4in Dupaque GEN-11130 Gentell Hydrogel Wound Dressing 3oz / 85g 73231-02 - Cutimed Hydrocontrol Curad “Soothe & Cool” Dressing (74 x 45mm) ZGIH44 HYDROGEL IMPREGNATED GAUZE DRESSING 4"X 4" Reliamed 6030-4157 - Glaciergel 61-53022 HYDROGEL IMPREGNATED GAUZE DRESSING 2"X 2" MCKESSON DUP81110 Aquasite Amorphous Hydrogel Dressings 1 fl oz Bellows G025 Amorphous Hydrogel with Alginate 1oz/25g Curad “Soothe & Cool” Dressing (56 x 26mm) GEN-11700 Gentell Hydrogel Sheet Dressing Borderless 7” x 5” (17.8cm x 12.7cm) DUP53044 Aquasite Impregnated Gauze Size 4" x 4" CWL 1004 - KerraLite Cool 6030-4156 - Glaciergel CWL 1008 - KerraLite Cool Border 73231-00 - Cutimed Hydrocontrol CBL-1212-118 12"X12" FOAM DRESSING BSN7261002- Cutimed Hydrogel 25 grams tube w/applicator 53022 Aquasite Impregnated Gauze Size 2" x 2" Medela Breast Pads (USA) CVS86433-9 Xtrasorb HCS Non-Adhesive 3"x3" (cvs) 73230-03 - Leukomed Control BSN7261001- Cutimed Hydrogel 15 grams tube w/applicator DUP86388-9 - Xtrasorb HCS Non-Adhesive DUP86433-9 - Xtrasorb HCS Non-Adhesive 53048 Aquasite Impregnated Gauze Size 4" x 8" 81110 HYDROGEL WOUND DRESSING 1 FL.OZ. MCKESSON Russell Chest Seal CWL 1009 - KerraLite Cool Border 73230-01 - Leukomed Control G085 Amorphous Hydrogel with Alginate 3oz/85g CWL 1007 - KerraLite Cool Border CWL 1005 - KerraLite Cool DH-03 Dermagran Hydrogel Wound Dressing 3oz DUP81122 Aquasite Hydrogel Impregnated Non-Woven Dressing 2" x 2" GEN-11470 Gentell Hydrogel Sheet Dressing Borderless 4.7” x 3.4” (12cm x 8.6cm) CBL-0206- 118 2"X 6" FOAM DRESSING DUP81144 Aquasite Hydrogel Impregnated Non-Woven Dressing 2" x 2" 73231-01 - Cutimed Hydrocontrol 61-53044 HYDROGEL IMPREGNATED GAUZE DRESSING 4"X 4" MCKESSON 73230-02 - Leukomed Control 73230-05 - Leukomed Control 73230-00 - Leukomed Control 40-2979 - Hydrogel Dressing DUP86344-9 Xtrasorb HCS 4.5"x4.5" CVS53022-4 CVS MOIST COOLING BURN PAD 2" X 2" GEN-11240 Gentell Hydrogel Sheet Dressing Borderless 2.4” x 2.4” (6cm x 6cm) CWL 1006 - KerraLite Cool 73231-03 - Cutimed Hydrocontrol DUP86466-9 - Xtrasorb HCS Adhesive DUP86322-9 Xtrasorb HCS 2.3"x2.3" DUP53048 Aquasite Impregnated Gauze Size 4" x 8" CBL-0404 - 118 4"X 4" FOAM DRESSING CBL-0808-118 8"X 8" FOAM DRESSING BSN7261000- Cutimed Hydrogel 8 grams tube w/applicator BSN7261003- Cutimed Hydrogel 15 grams tube DUP77784 Dutex 100% Cotton 2 ply conforming Bandage 6" x 4.1 yd Sterile DUP75104 Duform Synthetic Conforming Bandage 4" x 4.1 yd Non-Sterile DUP77782 Dutex 100% Cotton 2 ply conforming Bandage 3" x 4.1 yd Sterile DUP75102 Duform Synthetic Conforming Bandage 2" x 4.1 yd Non-Sterile DUP77783 Dutex 100% Cotton 2 ply conforming Bandage 4" x 4.1 yd Sterile DUP9333 Gazetex 100% Cotton , 6-ply, Fluff Sponge 6" x 6-3/4" Non -Sterile DUP9334 Gazetex 100% Cotton , 6-ply, Fluff Sponge 7-3/4" x 8-3/4" Non- Sterile DUP76784 Dutex 100% Cotton 2 ply conforming Bandage 6" x 4.1 yd Non-Sterile DUP9322 Gazetex Bandage Rolls 4-1/2" x 4.1 yds, 6 ply Sterile DUP75106 Duform Synthetic Conforming Bandage 6" x 4.1 yd Non-Sterile DUP76781 Dutex 100% Cotton 2 ply conforming Bandage 2" x 4.1 yd Non-Sterile DUP75206 Duform Synthetic Conforming Bandage 6" x 4.1 yd Sterile DUP9345 Gazetex 100% Cotton , 6-ply, Fluff Sponge 7-3/4" x 8-3/4" Sterile DUP9320-48 Gazetex Bandage Rolls 4-1/2" x 4.1 yds, 6 ply Non-Sterile DUP9340 Gazetex 100% Cotton , 6-ply, Fluff Sponge 6" x 6I-3/4" Sterile DUP9320 Gazetex Bandage Rolls 4-1/2" x 4.1 yds, 6 ply Non-Sterile DUP76782 Dutex 100% Cotton 2 ply conforming Bandage 3" x 4.1 yd Non-Sterile DUP77781 Dutex 100% Cotton 2 ply conforming Bandage 2" x 4.1 yd Sterile DUP75204 Duform Synthetic Conforming Bandage 4" x 4.1 yd Sterile DUP75203 Duform Synthetic Conforming Bandage 3" x 4.1 yd Sterile DUP75103 Duform Synthetic Conforming Bandage 3" x 4.1 yd Non-Sterile DUP76783 Dutex 100% Cotton 2 ply conforming Bandage 4" x 4.1 yd Non-Sterile DUP9321 Gazetex Bandage Rolls 2-1/2" x 3 yds, 6 ply Sterile DUP75202 Duform Synthetic Conforming Bandage 2" x 4.1 yd Sterile DuCare 59120 Pak-Its Gauze Plain Packing Strips with Strip Delivery System Size 1/4" x 5 yd 59220 Pak-Its Gauze Plain Packing Strips with Strip Delivery System Size 1/2" x 5 yd 59421 Pak-Its Gauze Plain Packing Strips Size 2" x 5 yd 59121 Pak-Its Gauze Plain Packing Strips Size 1/4" x 5 yd 59221 Pak-Its Gauze Plain Packing Strips Size 1/2" x 5 yd 59321 Pak-Its Gauze Plain Packing Strips Size 1" x 5 yd 59420 Pak-Its Gauze Plain Packing Strips with Strip Delivery System 2" x 5 yd 59320 Pak-Its Gauze Plain Packing Strips with Strip Delivery System Size 1" x 5 yd DUP50100 Wet Dressing 4" x 8" Water DUP50120 Wet Dressing 4" x 8" Saline NG25- NASO GASTRIC STRIP ADULT DUP62039 Ultrafix Self-Adhesive Dressing Covering (8" x 10.9yds /20cm x 10m) DUP62036 Ultrafix Self-Adhesive Dressing Covering (2" x 10.9yds /5cm x 10m) P5LB/548/G2/2 Aquaheal Second Skin NG40- NASO GASTRIC STRIP PEDIATRIC CS50-CATH-STRIP CATHETER FASTENER GEN-10640 Gentell FixTape 4" x 11yards NG60- NASO GASTRIC STRIP INFANT NG50- NASO GASTRIC STRIP ADULT P3LB/548/G2/2 Aquaheal Second Skin UC20- UC-STRIP CATHETER TUBING FASTENER DA3XS/631/C1/2 V.A.C. Seal Hydrogel Strip GEN-10600 Gentell FixTape 2" x 11yards GEN-10625 Silicone Fixtape 2"x5 Yards DUP62037 Ultrafix Self-Adhesive Dressing Covering (4" x 10.9yds /10cm x 10m) DUP62038 Ultrafix Self-Adhesive Dressing Covering (6" x 10.9yds /15cm x 10m) Collagen Particles 1g Burnfree GEN- 15450 Gentell Rolled Gauze Bandage 4.5" x 4.1 YDS GEN-15310 Gentell Conforming Stretch Gauze 3" x 75" DERMGRAN 9891 Curi-Strip 1/4"X1-1/2" DKC81119 Shur Strip Wound Closure Strip 1/4" x 1 -1/2 " Sterile TP1102-WOUND CLOSURE STRIP 1/4X4" TS3103-WOUND CLOSURE STRIP 1/2X4" TP1103-WOUND CLOSURE STRIP 1/2X4" TS3102-WOUND CLOSURE STRIP 1/4X4" DKC81121 Shur Strip Wound Closure Strip 1/2" x 4" Sterile 9892 Curi-Strip 1/4" x 3" DKC81118 Shur Strip Wound Closure Strip 1/4" x 3" Sterile TP1101-WOUND CLOSURE STRIP 1/4X3" TS3100-WOUND CLOSURE STRIP 1/8X3" TP1105-WOUND CLOSURE STRIPS, 1X5" TP1104-WOUND CLOSURE STRIP ¼” X1-1/2" TS3101-WOUND CLOSURE STRIP 1/4X3" DKC71153 Shur Strip Wound Closure Strip 1/2" x 4 " Non-Sterile TP1100-WOUND CLOSURE STRIP, 1/8"X3" 9894 Curi-Strip 1/2"X 4" DKC81120 Shur Strip Wound Closure Strip 1/4" x 4" Sterile TS3104-WOUND CLOSURE STRIP 1/4X1-1/2" 6

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-10-28
MCZ Suture Removal Kit General, Plastic Surgery Class 1 878.4800 2022-10-28
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-10-28
LGH Instrument, Cast Removal, Ac-Powered Orthopedic Class 1 888.5960 2022-10-31
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-10-28
FRO Dressing, Wound, Drug Unknown Class U N/A 2026-03-30
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2022-10-28
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2022-10-28
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-10-28
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2022-10-28
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-06-18
FER Anoscope And Accessories Gastroenterology, Urology Class 2 876.1500 2022-10-28
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2025-01-15
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2022-10-28
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2008-09-02
EFQ Gauze/Sponge, Internal Unknown Class U N/A 2022-10-28
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2022-10-28
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2024-07-17
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-10-28
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2008-09-02
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2022-10-28
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2008-09-02
EFQ Gauze/Sponge, Internal Unknown Class U N/A 2022-10-28
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2022-10-28
EFQ Gauze/Sponge, Internal Unknown Class U N/A 2022-10-28
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-10-28
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2008-09-02
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2024-06-18
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2022-10-28
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2008-09-02
MGP Dressing, Wound And Burn, Occlusive Unknown Class U N/A 2022-10-28
FPX Strip, Adhesive, Closure, Skin General Hospital Class 1 880.5240 2022-10-28

Official Correspondent

No official correspondent registered.

US Agent Details

Michael Alford Business: GENTELL Email: malford@gentell.com Phone: (800) 8409041

Related Public Records

Same Entity

GENTELL
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9680731 FIRST WATER RAMSBURY LTD Marlborough Wiltshire, GB
2530957 GENTELL Bristol, PA, US
3003636207 DERMA SCIENCES NANTONG INCORPORATION DEVELOPMENT Jiangsu, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30
K954741 Derma Sciences, Inc. DERMAGRAN WENT DRESSING (DEXTROSE-SALINE) 1995-11-01
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31
K861444 Surgical Specialties, Inc. S1 NASAL PACKING 1986-05-06
K863737 Hermitage Hospital Products, Inc. SPONGES STERILE TWIN PAKT AND SINGLES 1986-10-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0001-05 DeRoyal Wound Care U
Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***
Z-0013-2019 COVIDIEN LLC 1
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680091. Last updated year: 2026. Please use registration number 9680091 when referencing this establishment in official correspondence.
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