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Single Use Aspiration Needle NA-220H/230H NA-220H-8025

by Olympus Medical Systems Corporation 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number04953170309199 UDI-DI Date2 Jul 2018ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1069-2021 FDA Class II initiated 4 Jan 2021

    Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Single Use Aspiration Needle NA-220H/230H
Generic Name
General-purpose endoscopic needle, single-use
Model / Reference
NA-220H-8025
Primary DI / UDI-DI
04953170309199
510(k) Number
FDA Product Code
FCG
GMDN Term
General-purpose endoscopic needle, single-use
Device Class
Class II
Regulation Number
876.1075
GUDID distribution status
Not in Commercial Distribution

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

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