DERMA SCIENCES NANTONG INCORPORATION

FDA Device Registration & Listing · DEVELOPMENT Jiangsu, CN · Registration 3003636207

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
3003636207
FEI Number
3003636207
Entity Name
DERMA SCIENCES NANTONG INCORPORATION
City/State/Country
DEVELOPMENT Jiangsu, CN
Establishment Address
NO. 24 TONGZHOU ROAD, NANTONG, ECONOMIC AND TECHNOLOGICAL, DEVELOPMENT Jiangsu JIANGSU, CN
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
N/A
PMA Number
N/A

All Registered Proprietary Names

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" GEN- 15450 Gentell Rolled Gauze Bandage 4.5" x 4.1 YDS GEN-15310 Gentell Conforming Stretch Gauze 3" x 75" Liquid Bandage, Wound Cleanser 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 DuCare Dupaque 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 Derma Wound Kit DERMGRAN TCC-EZ Saw Wound measuring kit Burnfree CS50 - Cath-Strip Reclosable Catheter Fastener 95X102 mm Duflex Conforming Bandage Burnfree 4 Oz and 2 Oz 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 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 Burnfree 1/8 Oz 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 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 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" Aquasite Hydrogel Would Dressing 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) Surecare Eye pad

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
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2008-09-02
KMF Bandage, Liquid General Hospital Class 1 880.5090 2022-10-28
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2022-10-28
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2022-10-28
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2022-10-28
EFQ Gauze/Sponge, Internal Unknown Class U N/A 2022-10-28
MCZ Suture Removal Kit General, Plastic Surgery Class 1 878.4800 2022-10-28
MGP Dressing, Wound And Burn, Occlusive Unknown Class U N/A 2022-10-28
LGH Instrument, Cast Removal, Ac-Powered Orthopedic Class 1 888.5960 2022-10-31
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2022-10-28
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2022-10-28
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2025-01-15
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
FER Anoscope And Accessories Gastroenterology, Urology Class 2 876.1500 2022-10-28
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2008-09-02
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2022-10-28
FPX Strip, Adhesive, Closure, Skin General Hospital Class 1 880.5240 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
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2022-10-28
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2008-09-02
HMP Pad, Eye General, Plastic Surgery Class 1 878.4440 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
9680091 DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.) TORONTO Ontario, CA

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
K954741 Derma Sciences, Inc. DERMAGRAN WENT DRESSING (DEXTROSE-SALINE) 1995-11-01
K790050 Stanford Professional Products SPONGES, STANFORD STERILE LAP 1979-01-17
K861444 Surgical Specialties, Inc. S1 NASAL PACKING 1986-05-06

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 3003636207. Last updated year: 2026. Please use registration number 3003636207 when referencing this establishment in official correspondence.
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