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Gingi-Plain Max Z-Twist 11172M

by Gingi Pak

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00818746020073 UDI-DI Date26 Aug 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  • Withdrawn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
Gingi-Plain Max Z-Twist
Generic Name
Gingival retraction cord, non-medicated
Model / Reference
11172M
Primary DI / UDI-DI
00818746020073
FDA Product Code
JES
GMDN Term
Gingival retraction cord, non-medicated
Device Class
Class I
Regulation Number
872.6390
GUDID distribution status
In Commercial Distribution

Other devices from Gingi Pak

Properties

  • Single Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No