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Avalon Biomed by Zarc BlueShaper PRO sterile File 31mm ZXS-Z5 ZBS31APROS

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 Number00810118105623 UDI-DI Date10 Mar 2025ListedStatusListed 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  • Withdrawn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
Avalon Biomed by Zarc BlueShaper PRO sterile File 31mm ZXS-Z5
Generic Name
Rotary/reciprocating endodontic file/rasp, single-use
Model / Reference
ZBS31APROS
Primary DI / UDI-DI
00810118105623
FDA Product Code
EKS
GMDN Term
Rotary/reciprocating endodontic file/rasp, single-use
Device Class
Class I
Regulation Number
872.4565
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rotary/reciprocating endodontic file/rasp, single-use

Other devices from Nusmile, Ltd

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Properties

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

Other properties (10)

  • 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
  • Manufacturing Date: No