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Opti-Tatt UTRT-4300

by Qfix GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841439115251 UDI-DIDate29 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Opti-Tatt
Generic Name
Skin marking transfer paper
Model / Ref / Catalog
UTRT-4300
Primary DI / UDI-DI
00841439115251
FDA Product Code
FZZ
GMDN Term
Skin marking transfer paper
Device Class
Class I
Regulation Number
878.4660
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No