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 |
| 3006518081 | 3006518081 | NEWMED INC | 1 | Y | 2026-01-01 | 11231 NW 20th St Unit 137 Miami FL US 33172 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00816465021005 | NewGel+ Silicone Gel Sheeting - "NG-363 NewGel+ Clear Silicone Abdomen Sheet, 2""x18"" (5.1x45.7cm), 1 pc/package" | 847-412-1000 | regulatory@newmedical.com |
| 00816465021012 | NewGel+ Silicone Gel Sheeting - "NG-164 NewGel+ Beige Silicone Abdomen Sheet, 2""x24"" (5.1x61.0cm), 1 pc/package" | 847-412-1000 | regulatory@newmedical.com |
| 00816465021029 | NewGel+ Silicone Gel Sheeting - "NG-364 NewGel+ Clear Silicone Abdomen Sheet, 2""x24"" (5.1x.61.0cm), 1 pc/package" | 847-412-1000 | regulatory@newmedical.com |
| 00816465021036 | NewGel+ Silicone Gel Sheeting - "NG-170 NewGel+ Beige Silicone Blanket, 10""x24"" (25.4x61.0cm), 1 pc/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.
NEWMED CORP.
NEWMED CORP.
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