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EdgeEndo NITIKF6021

by Hsg-S Corp

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 Number00810213811689 UDI-DIDate1 Sep 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  • Withdrawn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
EdgeEndo
Generic Name
Manual endodontic file/rasp, single-use
Model / Reference
NITIKF6021
Primary DI / UDI-DI
00810213811689
FDA Product Code
EKS
GMDN Term
Manual endodontic file/rasp, single-use
Device Class
Class I
Regulation Number
872.4565
GUDID distribution status
In Commercial Distribution

Other devices from Hsg-S Corp

See all devices from Hsg-S Corp →

Properties

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

Other properties (10)

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