IsoMark™ UTRT-3101
by Bionix, LLC
IsoMark UTRT-3101, a tattoo ink (FDA Class I; FDA product code FZZ, Marker, Skin) made by Bionix, LLC, was listed in FDA GUDID on 27 Oct 2022 (UDI-DI 00714646000910); the registry lists it as not in commercial distribution (GUDID) as of 22 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 | Number00714646000910 | Date27 Oct 2022 | StatusListed |
Official records
- AccessGUDID record 00714646000910
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- IsoMark™
- Generic name
- Tattoo ink, dermal
- Model / Ref / Catalog
- UTRT-3101, 3101
- Primary DI / UDI-DI
- 00714646000910
- FDA product code
- FZZ
- GMDN term
- Tattoo ink, dermal
- Device class
- Class I
- Regulation number
- 878.4660
- GUDID distribution status
- Not in Commercial Distribution
- Sterilisation method
- Radiation Sterilization
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