Skip to content

Na AG-5311-2423-2106

by Hangzhou AGS MedTech Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number06959664931899 UDI-DI Date1 Dec 2021ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
General-purpose endoscopic needle, single-use
Model / Reference
AG-5311-2423-2106
Primary DI / UDI-DI
06959664931899
510(k) Number
FDA Product Code
FBK
GMDN Term
General-purpose endoscopic needle, single-use
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose endoscopic needle, single-use

Cleared under the same submission (K190032)

Show all (12)

Other devices from Hangzhou AGS MedTech Co., Ltd.

See all devices from Hangzhou AGS MedTech Co., Ltd. →

Properties

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

Other properties (8)

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