Derma Sciences Nantong Incorporation
Registered establishment in Development, Jiangsu, China. 19 device types.
Derma Sciences Nantong Incorporation is a contract manufacturer holding a current FDA establishment registration. The registration covers Pad, Eye, Bandage, Cast and 17 other device types. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | DERMA SCIENCES NANTONG INCORPORATION |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003636207 |
| FEI number | 3003636207 |
| Establishment type | Contract manufacturer, Complaint-file establishment, Manufacturer |
Location
| City | Development |
|---|---|
| Province | Jiangsu |
| Address | NO. 24 TONGZHOU ROAD, NANTONG |
| Postal code | JIANGSU |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Anoscope And Accessories | Class 2 | 59445 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 2″ x 5 yd, 59346 Pak-Its Gauze Iodoform Packing Strips Size 1″ x 5 yd, 59345 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 1″ x 5 yd, 59146 Pak-Its Gauze Iodoform Packing Strips Size 1/4″ x 5 yd, 59145 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 1/4″ x 5 yd, 59246 Pak-Its Gauze IodoformPacking Strips Size 1/2″ x 5 yd and 1 more | 2022 | 3 |
| Bandage, Cast | Class 1 | TCC2GSII TCC Cast Mede-Kast – Case OF 10’S…PK:10/CASE, TCC2MDKK TCC Cast Mede-Kast – Case OF 10’S…PK:10/CASE, TCC2-1126 TCC-EZ X-Large Charcot BOOT…PK:1/CS, TCC2ULTR Mede Kast Casting SYSTEM…PK:10/CASE, TCC2-3001 TCC-EZ Casting System 3″ Case OF 10 Without BOOTS…PK:10/CS, TCC2-4214 TCC-EZ Casting System 4″ Case OF 10 With 2 Large Boots and 19 more | 2022 | 81 |
| Bandage, Elastic | Class 1 | GEN-10350 Cohesive Wrap Tan Color 3x5yds, GL2522-Surgilast Tubular Elastic Dressing Retainer Size 22 – 25 Yards Stretched, GL706-Surgilast Tubular Elastic Dressing Retainer Size 5-1/2 – 25 Yards Stretched, GL713-Surgilast Tubular Elastic Dressing Retainer Size 12 – 25 Yards Stretched, GL704-Surgilast Tubular Elastic Dressing Retainer Size 4 – 25 Yards Stretched, Dusor Elastic Bandage and 45 more | 2022 | 280 |
| Bandage, Liquid | Class 1 | Liquid Bandage, Wound Cleanser | 2022 | 3 |
| Device, Intravascular Catheter Securement | Class 1 | CS50 – Cath-Strip Reclosable Catheter Fastener 95X102 mm | 2025 | 33 |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | Class U | Burnfree, Aquasite Hydrogel Would Dressing, Burnfree 1/8 Oz, DuCare, Burnfree 4 Oz and 2 Oz | 2022 | 1 |
| Dressing, Wound And Burn, Occlusive | Class U | Dermgran | 2022 | 1 |
| Dressing, Wound, Drug | Class U | GEN-13620 Gentell Calcium Alginate Ag 6″ x 6″, GEN 13420 Gentell Calcium Alginate Ag 4″ x 4″, GEN-13220 Gentell Calcium Alginate Ag 2″ x 2″, DUP88544 Algicell Ag Calcium Alginate Dressing 4.25″ x 4.25″, DUP88512 Algicell Ag Calcium Alginate Dressing 0.75″ x 12″, DUP88582 Algicell Ag Calcium Alginate Dressing 8 x 12″ and 14 more | 2022 | 48 |
| Dressing, Wound, Occlusive | Class 1 | DUP87059 Dupad Abdominal Pad 5″ x 9″ Sterile, DUP87810 Dupad Abdominal Pad 8″ x 10″ Sterile, DUP97188 Dupad Abdominal Pad 8″ x 7-1/2″ Non-Sterile, DUP97110 Dupad Abdominal Pad 8″ x 10″ Non-Sterile, DUP97159 Dupad Abdominal Pad 5″ x 9″ Non -Sterile, DUP87088 Dupad Abdominal Pad 8″ x 7-1/2″ Sterile and 44 more | 2008 | 183 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | DUP9322- Gazetex gauze bandage roll 4.5 in X 4.1 yards, GEN- 15450 Gentell Rolled Gauze Bandage 4.5″ x 4.1 YDS, GEN-15310 Gentell Conforming Stretch Gauze 3″ x 75″ | 2008 | 266 |
| Gauze/Sponge, Internal | Class U | Duflex Conforming Bandage, 59321 Pak-Its Gauze Plain Packing Strips Size 1″ x 5 yd, 59220 Pak-Its Gauze Plain Packing Strips with Strip Delivery System Size 1/2″ 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, 59421 Pak-Its Gauze Plain Packing Strips Size 2″ x 5 yd and 26 more | 2022 | 8 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Dupaque | 2022 | 67 |
| Instrument, Cast Removal, Ac-Powered | Class 1 | TCC-EZ Saw | 2022 | 4 |
| Pad, Eye | Class 1 | Surecare Eye pad | 2022 | 100 |
| Strip, Adhesive, Closure, Skin | Class 1 | TS3103-WOUND Closure Strip 1/2X4″, DKC81120 Shur Strip Wound Closure Strip 1/4″ x 4″ Sterile, TS3104-WOUND Closure Strip 1/4X1-1/2″ 6, DKC81118 Shur Strip Wound Closure Strip 1/4″ x 3″ Sterile, TS3101-WOUND Closure Strip 1/4X3″, TP1105-WOUND Closure Strips, 1X5″ and 13 more | 2022 | 14 |
| Suture Removal Kit | Class 1 | Derma Wound Kit | 2022 | 12 |
| Tape And Bandage, Adhesive | Class 1 | CS50-CATH-STRIP Catheter Fastener, DUP62037 Ultrafix Self-Adhesive Dressing Covering (4″ x 10.9yds /10cm x 10m), P3LB/548/G2/2 Aquaheal Second Skin, UC20- UC-Strip Catheter Tubing Fastener, GEN-10640 Gentell FixTape 4″ x 11yards, NG25- Naso Gastric Strip Adult and 10 more | 2008 | 353 |
| Tape, Measuring, Rulers And Calipers | Class 1 | Wound measuring kit | 2022 | 42 |
| Wound Dressing With Animal-Derived Material(S) | Class U | Gentell Collagen Wound Dressing; Particles, 2″x2″ and 4″x5.25″, Gentell Collagen Wound Dressing: 4″x4″, 7″x7″ | 2017 | 12 |
Clearances
No clearance names Derma Sciences Nantong Incorporation as applicant. 7 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K990180 | 1999-08-13 | MGQ | Traditional | Nortrade Medical, Inc. |
| K990179 | 1999-08-13 | MGQ | Traditional | Nortrade Medical, Inc. |
| K990178 | 1999-08-13 | MGQ | Traditional | Nortrade Medical, Inc. |
| K980861 | 1998-05-20 | MGQ | Traditional | Dumex Medical Surgical Products, Ltd. |
| K980791 | 1998-04-29 | EFQ | Traditional | Dumex Medical Surgical Products, Ltd. |
| K946326 | 1995-01-24 | EFQ | Traditional | Dumex Medical Surgical Products, Ltd. |
| K921291 | 1993-01-21 | FER | Traditional | Inman Medical Corp. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.