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Zarc by Avalon Biomed Gutta Perch Obturator (Pellets) 6344003

by Nusmile, Ltd

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810118103650 UDI-DI Date15 Jan 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  • Withdrawn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
Zarc by Avalon Biomed Gutta Perch Obturator (Pellets)
Generic Name
Natural gutta-percha
Model / Reference
6344003
Primary DI / UDI-DI
00810118103650
FDA Product Code
EKM
GMDN Term
Natural gutta-percha
Device Class
Class I
Regulation Number
872.3850
GUDID distribution status
In Commercial Distribution

Other devices from Nusmile, Ltd

See all devices from Nusmile, Ltd →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

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