NEWGEL AND NEWGEL PLUS E
NEWMEDICAL TECHNOLOGY, INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005369309 | 3005369309 | NEWMEDICAL TECHNOLOGY, INC. | 1 | N | 2026-01-01 | 4065 Commercial Avenue NORTHBROOK IL US 60062 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00816465020008 | NewGel+ Silicone Gel Sheeting - "NG-365 NewGel+ Clear Silicone Abdomen Sheet, 2""x8"" (5.1 x20.3cm), 1 pc/package" | 847-412-1000 | regulatory@newmedical.com |
| 00816465020015 | NewGel+ Silicone Gel Sheeting - "NG-165 NewGel+ Beige Silicone Abdomen Sheet, 2""x8""(5.1 x20.3cm), 1 pc/package" | 847-412-1000 | regulatory@newmedical.com |
| 00816465020046 | NewGel+UV Silicone Gel for Scars + SPF30 - 8015 NewGel+UV Silicone Gel, 0.5 oz. (15 gram), 1 tube/package | 847-412-1000 | regulatory@newmedical.com |
| 00816465020213 | Silagen 100% Pure Silicone Gel - 6115 Silagen Pure Silicone Gel, 0.5oz. (15 gram), 1 bottle/package | 847-412-1000 | regulatory@newmedical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 63710 | 1593250557 | K121361 | CURALINE POLYURETHANE FOAM AWC DRESSING | FRO | 2012-11-30 |
| 63710 | 1984664606 | K041704 | NEWGEL AND NEWGEL PLUS E | MDA | 2005-10-17 |
| 63710 | 1019077866 |
NEWMEDICAL TECHNOLOGY, INC.
NEWMEDICAL TECHNOLOGY, INC.
NEWMEDICAL TECHNOLOGY, INC.
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