FDA Registration
Active
🇨🇳 China
DERMA SCIENCES NANTONG INCORPORATION
Reg #: 3003636207
·
FEI: 3003636207
·
Expires 2026
Products
18
Proprietary Names
174
Establishment Types
3
Classifications
18
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Registration Details
- Registration Name
- DERMA SCIENCES NANTONG INCORPORATION
- Registration Number
- 3003636207
- FEI Number
- 3003636207
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO. 24 TONGZHOU ROAD, NANTONG, ECONOMIC AND TECHNOLOGICAL
- City
- DEVELOPMENT Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K980791
Owner / Operator
- Firm Name
- GENTELL
- Operator Number
- 10026501
- Address
- 180 Rittenhouse Circle
- City
- Bristol
- State
- PA
- Postal Code
- 19007
- Country
- US
US Agent
- Business Name
- Gentell
- Contact Name
- Michael Alford
- Address
- 1000 Floral Vale Blvd Ste 400
- City
- Yardley
- State
- PA
- ZIP
- 19067
- Country
- US
- [email protected]
- Phone
- 800 8409041 ext. 302
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2022-10-28 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2008-09-02 |
| Bandage, Liquid | KMF | Class 1 | General Hospital | No | 2022-10-28 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2022-10-28 |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | Class U | Unknown | No | 2022-10-28 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2022-10-28 |
| Gauze/Sponge, Internal | EFQ | Class U | Unknown | No | 2022-10-28 |
| Suture Removal Kit | MCZ | Class 1 | General, Plastic Surgery | No | 2022-10-28 |
| Dressing, Wound And Burn, Occlusive | MGP | Class U | Unknown | No | 2022-10-28 |
| Instrument, Cast Removal, Ac-Powered | LGH | Class 1 | Orthopedic | No | 2022-10-31 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2022-10-28 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2025-01-15 |
| Anoscope And Accessories | FER | Class 2 | Gastroenterology, Urology | No | 2022-10-28 |
| Strip, Adhesive, Closure, Skin | FPX | Class 1 | General Hospital | No | 2022-10-28 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2022-10-28 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2008-09-02 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2022-10-28 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2017-03-15 |
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
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
Gentell Collagen Wound Dressing; Particles, 2"x2" and 4"x5.25"
Gentell Collagen Wound Dressing: 4"x4", 7"x7"
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
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198