Cramer Orthogel 061935
Cramer Orthogel 061935 is a Class I device made by Cramer Products, Inc., listed in FDA GUDID since 1 Oct 2018 (UDI-DI 00311960620703), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00311960620703 | Date1 Oct 2018 | StatusListed |
Official records
- AccessGUDID record 00311960620703
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Cramer Orthogel
- Generic name
- Wound hydrogel dressing, non-sterile
- Model / reference
- 061935
- Primary DI / UDI-DI
- 00311960620703
- FDA product code
- NAE
- GMDN term
- Wound hydrogel dressing, non-sterile
- Device class
- Class I
- Regulation number
- 878.4022
- GUDID distribution status
- In Commercial Distribution
- Size
- Depth — 0.125 InchWidth — 12 InchLength — 12 Inch
Similar devices
Other devices filed under FDA product code NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic).
- Aquasite® 81110 DUP81110 by DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.)
- COMFEEL PURILON GEL, 15G(3900)/COMFEEL PURILON GEL, 25G(3903) by Coloplast Corp.
- CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION by New Dimensions IN Medicine, Inc.
- Cutimed® 72610-01 by BSN medical GmbH
- TRANSORB(TM) ULCER & WOUND DRESSING by Brady Medical Products Co.
- IP-758 BURN WOUND DRESSING by Exopack
- Aquasite® 53022 DUP53022 by DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.)
- ZENIEVA by Gorbec Pharmaceutical Services, Inc.
- Carbon Wave Patch CWP by FOCUS MEDICAL, LLC.
- Cutimed® 72610-00 by BSN medical GmbH