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IsoMark™ UTRT-3102

by Bionix, LLC

IsoMark UTRT-3102 is a tattoo ink (FDA Class I; FDA product code FZZ, Marker, Skin) made by Bionix, LLC, listed in FDA GUDID since 27 Oct 2022 (UDI-DI 00714646000927), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00714646000927 UDI-DI Date27 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
IsoMark™
Generic name
Tattoo ink, dermal
Model / Ref / Catalog
UTRT-3102, 3102
Primary DI / UDI-DI
00714646000927
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).

Other devices from Bionix, LLC

See all devices from Bionix, LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)