Bionix, LLC UTRT-3105
by Bionix, LLC
Bionix, LLC UTRT-3105 is a tattoo ink (FDA Class I; FDA product code FZZ, Marker, Skin) made by Bionix, LLC, listed in FDA GUDID since 14 Oct 2022 (UDI-DI 00859911004979), registry data 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 | Number00859911004979 | Date14 Oct 2022 | StatusListed |
Official records
- AccessGUDID record 00859911004979
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Bionix, LLC
- Generic name
- Tattoo ink, dermal
- Model / Ref / Catalog
- UTRT-3105, 3105
- Primary DI / UDI-DI
- 00859911004979
- FDA product code
- FZZ
- GMDN term
- Tattoo ink, dermal
- Device class
- Class I
- Regulation number
- 878.4660
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FZZ (MARKER, SKIN).
- 10725 Correct Site Marker; Round Regular Tip by XODUS MEDICAL, INC.
- SKIN MARKING PEN by Abco Dealers, Inc.
- 10412 Correct Site Marker; Sharpie Style; w/ Ruler by XODUS MEDICAL, INC.
- BLOOM TRANSPARENT STENCIL by Freckles Publications, Inc.
- Devon 31145892 by Cardinalhealth
- ACCU-LINE SURGICAL MARKER by Accu-Line
- DERMAMARKER by Dermacare Products, Inc.
- SURGICAL MARKING PEN by Richard-Allan Medical Ind., Inc.
- DISPOSABLE SKIN MARKING PEN by E.M. Adams
- SURGISCRIBE MARKING PEN by Surgicot, Inc.