Dermaclose 580111000011
by Synovis Micro Companies Alliance, Inc
Dermaclose 580111000011 (GEM204010) is a skin-closing tension device (FDA Class I; FDA product code MKY, System, Skin Closure) made by Synovis Micro Companies Alliance, Inc, listed in FDA GUDID since 27 Jun 2024 (UDI-DI 00844735006728), 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 | Number00844735006728 | Date27 Jun 2024 | StatusListed |
Official records
- AccessGUDID record 00844735006728
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Dermaclose
- Generic name
- Skin-closing tension device
- Model / Ref / Catalog
- 580111000011, GEM204010
- Primary DI / UDI-DI
- 00844735006728
- FDA product code
- MKY
- GMDN term
- Skin-closing tension device
- Device class
- Class I
- Regulation number
- 878.4320
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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- PHOENIX ETE TISSUE EXTENSION SYSTEM by Phoenix Biomedical Corp.
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