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KLOwen BRSLKT

by Zhejiang Headway Medical Equipment Co., 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number16970469419273 UDI-DI Date23 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  • Withdrawn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
KLOwen
Generic Name
Orthodontic bracket, metal
Model / Reference
BRSLKT
Primary DI / UDI-DI
16970469419273
FDA Product Code
EJF
GMDN Term
Orthodontic bracket, metal
Device Class
Class I
Regulation Number
872.5410
GUDID distribution status
In Commercial Distribution
Sterilization Method
High-level Disinfectant

Other devices from Zhejiang Headway Medical Equipment Co., Ltd

See all devices from Zhejiang Headway Medical Equipment Co., Ltd →

Properties

  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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