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AnchorKnot Suture Passer (2-0) PSZ-400-305

by Baylis Médicale Cie Inc

Listed FDA GUDID listing, not in commercial distribution

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 Number00685447001744 UDI-DI Date30 Nov 2016ListedStatusListed GUDID: not 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  • Withdrawn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
AnchorKnot Suture Passer (2-0)
Generic Name
Suturing unit, single-use
Model / Reference
PSZ-400-305
Primary DI / UDI-DI
00685447001744
FDA Product Code
HRX
GMDN Term
Suturing unit, single-use
Device Class
Class II
Regulation Number
888.1100
GUDID distribution status
Not in Commercial Distribution

Other devices from Baylis Médicale Cie Inc

See all devices from Baylis Médicale Cie Inc →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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