GENTELL

FDA Device Registration & Listing · Bristol, PA, US · Registration 2530957

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
2530957
FEI Number
1000522686
Entity Name
GENTELL
City/State/Country
Bristol, PA, US
Establishment Address
180 Rittenhouse Circle, Bristol, PA 19007, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
GENTELL (Owner Number: 10026501)
Owner / Operator Contact Address
180 Rittenhouse Circle, Bristol, PA 19007, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K240485
PMA Number
N/A

All Registered Proprietary Names

745-45 Wafer with adhesive 45mm 7000 Ostomy Hydrocolloid Strips SP30W Ostomy Skin Barrier Wipes 745-57 Wafer with adhesive 57mm 745-70 Wafer with adhesive 70mm 750-70 Wafer without adhesive 70mm SP30 Ostomy Skin Barrier 30g 1oz RA30 Ostomy Adhesive Remover 30g 1oz RA30W Ostomy Adhesive Remover Wipes PA060 Ostomy Paste 60g 2oz 750-57 Wafer without adhesive 57mm 750-45 Wafer without adhesive 45mm F12LB/648/C1/2 Dr Scholl's Blister Cushion Dressing F10LB/599/G2/2 Dr Scholl’s Corn Cushion - New Liner MM0071 Gentell Manuka Honey Fiber Dressing 4” x 5” (10cm x 12.5cm) (formerly MANUKAhd Super Lite 4” x 5” (10cm x 12.5cm) MM0031 Gentell Manuka Honey Fiber Select 4” x 5” (10 x 12.5cm) (formerly MANUKAhd Lite 4” x 5” (10 x 12.5cm)) MM0017 Gentell Manuka Honey Fiber Premium 4” x 5” (10 x 12.5cm) (formerly MANUKAhd 4” x 5” (10 x 12.5cm)) MM0013 Gentell Manuka Honey Fiber Premium 2” x 2” (5 x5cm) (formerly MANUKAhd  2” x 2” (5 x5cm)) MM0030 Gentell Manuka Honey Fiber Select 2” x 2”  (5 x 5cm) (formerly MANUKAhd Lite 2” x 2”  (5 x 5cm)) MM0070 Gentell Manuka Honey Fiber Dressing 2” x 2” (5cm x 5cm) (formerly MANUKAhd Super Lite 2” x 2” (5cm x 5cm)) 3250-00W Drainable pouch 1piece without adhesive opaque 13/64mm 3250-00C Drainable pouch 1piece without adhesive clear 13/64mm 3445-00W Drainable pouch 1piece adhesive opaque 13/80mm 3445-00C Drainable pouch 1piece adhesive clear 13/80mm 3450-00W Drainable pouch 1piece without adhesive opaque 13/80mm 3245-00W Drainable pouch 1piece adhesive opaque 13/64mm 3245-00C Drainable pouch 1piece adhesive clear 13/64mm 3450-00C Drainable pouch 1piece without adhesive clear 13/80mm 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 330G Ostomy Elastic Belt large 330P Ostomy Elastic Belt small 400 Ostomy Plastic Clamp 330M Ostomy Elastic Belt medium GEN- 13420, Calcium Alginate Ag (Silver) 4" x 4" Dressing GEN- 13620, Calcium Alginate Ag (Silver) 6" x 6" Dressing GEN- 13820, Calcium Alginate Ag (Silver) 8" x 8" Dressing GEN- 13482, Calcium Alginate Ag (Silver) 4" x 8" Dressing GEN- 13220, Calcium Alginate Ag (Silver) 2" x 2" Dressing GEN-13142, Calcium Alginate Ag(Silver)12 inch Rope Dressing MM0048 Gentell Manuka Honey Wound Dressing 20g (formerly MANUKApli 20g) MM0049 Gentell Manuka Honey Wound Dressing 15g (formerly MANUKApli 15g) MM0051 Gentell Manuka Honey Wound Dressing 44g (formerly MANUKApli 44g) GEN-10355 Elastic Ace Fixwrap 3x5 GEN-10455 Elastic Ace Fixwrap 4x5 GL715-Surgilast Tubular Elastic Dressing Retainer Size 14 - 25 Yards Stretched GL707-Surgilast Tubular Elastic Dressing Retainer Size 6 - 25 Yards Stretched GL512-Surgilast Tubular Elastic Dressing Retainer Size 11- 50 Yards Stretched GL708-Surgilast Tubular Elastic Dressing Retainer Size 7 - 25 Yards Stretched GL505-Surgilast Tubular Elastic Dressing Retainer Size 5 - 50 Yards Stretched GL722-Surgilast Tubular Elastic Dressing Retainer Size 5 - 10 Yards Stretched GL503-Surgilast Tubular Elastic Dressing Retainer Size 3 - 50 Yards Stretched BulkNet GL705-Surgilast Tubular Elastic Dressing Retainer Size 5 - 25 Yards Stretched GL509-Surgilast Tubular Elastic Dressing Retainer Size 8 - 50 Yards Stretched DUP75103 DUFORM CONFORMING BANDAGES 3"x4.1yds Non sterile DUP75106 DUFORM CONFORMING BANDAGES 6"x4.5yds Non sterile Stockingnette GL720- Surgilast Tubular Elastic Dressing Retainer Size 3 - 10 Yards Stretched GL726-Surgilast Tubular Elastic Dressing Retainer Size 10 - 10 Yards Stretched DUP75202 DUFORM CONFORMING BANDAGES 2"x4.1yds Sterile GL508-Surgilast Tubular Elastic Dressing Retainer Size 7 - 50 Yards Stretched GL704-Surgilast Tubular Elastic Dressing Retainer Size 4 - 25 Yards Stretched Dusor Elastic Bandage Pressure Bandage GL724-Surgilast Tubular Elastic Dressing Retainer Size 6 - 10 Yards Stretched GL502- Surgilast Tubular Elastic Dressing Retainer Size 2 - 50 Yards Stretched GL709-Surgilast Tubular Elastic Dressing Retainer Size 8 - 25 Yards Stretched DUP75102 DUFORM CONFORMING BANDAGES 2"x4.1yds Non sterile GL710-Surgilast Tubular Elastic Dressing Retainer Size 9 - 25 Yards Stretched GEN-10650 Cohesive Wrap Tan Color 6x5yds GL2522-Surgilast Tubular Elastic Dressing Retainer Size 22 - 25 Yards Stretched GEN-10655 Elastic Ace Fixwrap 6x5 GL702- Surgilast Tubular Elastic Dressing Retainer Size 2 - 25 Yards Stretched GL504-Surgilast Tubular Elastic Dressing Retainer Size 4 - 50 Yards Stretched GL506-Surgilast Tubular Elastic Dressing Retainer Size 5-1/2 - 50 Yards Stretched Suritube GEN-10350 Cohesive Wrap Tan Color 3x5yds GL511-Surgilast Tubular Elastic Dressing Retainer Size 10 - 50 Yards Stretched GL703- Surgilast Tubular Elastic Dressing Retainer Size 3 - 25 Yards Stretched DUP75204 DUFORM CONFORMING BANDAGES 4"x4.1yds Sterile GL510-Surgilast Tubular Elastic Dressing Retainer Size 9 - 50 Yards Stretched Compriband GL712-Surgilast Tubular Elastic Dressing Retainer Size 11 - 25 Yards Stretched GL713-Surgilast Tubular Elastic Dressing Retainer Size 12 - 25 Yards Stretched DUP75104 DUFORM CONFORMING BANDAGES 4"x4.1yds Non sterile GL714-Surgilast Tubular Elastic Dressing Retainer Size 13 - 25 Yards Stretched GL706-Surgilast Tubular Elastic Dressing Retainer Size 5-1/2 - 25 Yards Stretched GL503- Surgilast Tubular Elastic Dressing Retainer Size 3 - 50 Yards Stretched Flexoplast DUP75206 DUFORM CONFORMING BANDAGES 6"x4.5yds Sterile DUP75203 DUFORM CONFORMING BANDAGES 3"x4.1yds Sterile GL501- Surgilast Tubular Elastic Dressing Retainer Size 1 - 50 Yards Stretched GL711-Surgilast Tubular Elastic Dressing Retainer Size 10- 25 Yards Stretched GL507-Surgilast Tubular Elastic Dressing Retainer Size 6 - 50 Yards Stretched 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) GEN- 15450 Gentell Rolled Gauze Bandage 4.5" x 4.1 YDS GEN-15310 Gentell Conforming Stretch Gauze 3" x 75" GEN13066 Gelling Fiber Ag Dressing 6”x6” (15cmx15cm) GEN13044 Gelling Fiber Ag Dressing 4”x4” (10cmx10cm) GEN13022 Gelling Fiber Ag Dressing 2”x2” (5cmx5cm)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EXE Protector, Ostomy Gastroenterology, Urology Class 1 876.5900 2025-08-27
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2024-09-13
FRO Dressing, Wound, Drug Unknown Class U N/A 2026-03-20
EXH Bag, Urinary, Ileostomy Gastroenterology, Urology Class 1 876.5900 2025-08-27
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2008-09-02
EZR Cement, Stomal Appliance, Ostomy Gastroenterology, Urology Class 1 876.5900 2025-08-27
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-02-14
FRO Dressing, Wound, Drug Unknown Class U N/A 2026-03-20
FQM Bandage, Elastic General Hospital Class 1 880.5075 2022-10-28
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2008-09-02
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2008-09-02
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-08-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
9680091 DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.) TORONTO Ontario, CA
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
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29

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-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.
Z-0015-2019 COVIDIEN LLC 1
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 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 2530957. Last updated year: 2026. Please use registration number 2530957 when referencing this establishment in official correspondence.
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