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Retraxil blue 66101276

by KULZER GmbH

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberJ014661012760 UDI-DI Date21 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Retraxil blue
Generic name
Gingival retraction solution
Model / Ref / Catalog
66101276
Primary DI / UDI-DI
J014661012760
FDA product code
MVL
GMDN term
Gingival retraction solution
Device class
U
GUDID distribution status
In Commercial Distribution

Other devices from KULZER GmbH

See all devices from KULZER GmbH →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No