Dialfix 21 01
by Dfix
Dialfix 21 01 is a skin-closing tension device (FDA Class I; FDA product code MKY, System, Skin Closure) made by Dfix, listed in FDA GUDID since 28 Jan 2023 (UDI-DI 08800125000051), 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 | Number08800125000051 | Date28 Jan 2023 | StatusListed |
Official records
- AccessGUDID record 08800125000051
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Dialfix 21
- Generic name
- Skin-closing tension device
- Model / reference
- 01
- Primary DI / UDI-DI
- 08800125000051
- FDA product code
- MKY
- GMDN term
- Skin-closing tension device
- Device class
- Class I
- Regulation number
- 878.4320
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MKY (System, Skin Closure).
- PROXIDERM (D-460, D 90 460, D 180, 460, PS 460) by Progressive Surgical Products, Inc.
- PROXIDERM, MODELS TN 460, TN 90 460, BK 460 by Progressive Surgical Products, Inc.
- SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM by Life Medical Sciences, Inc.
- PHOENIX ETE TISSUE EXTENSION SYSTEM by Phoenix Biomedical Corp.
- WISEBANDS SKIN CLOSURE DEVICE by Wisebands, Ltd.