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05Y Metal Self-Ligating Tube -10 UL/LR TB05Y-C

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06970469419214 UDI-DI Date26 Nov 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  • Withdrawn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
05Y Metal Self-Ligating Tube -10 UL/LR
Generic Name
Orthodontic tube
Model / Reference
TB05Y-C
Primary DI / UDI-DI
06970469419214
FDA Product Code
DZD
GMDN Term
Orthodontic tube
Device Class
Class I
Regulation Number
872.5410
GUDID distribution status
In Commercial Distribution
Sterilization Method
Sound Waves

Other devices from Zhejiang Headway Medical Equipment Co., Ltd

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

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