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Na 838349

by Richard Wolf GmbH

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 Number04055207040089 UDI-DI Date9 Aug 2022ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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, reusable
Model / Ref / Catalog
838349, 8383.49
Description
CANNULA FOR PUNCTION Ø 4.7MM WL 320MM tip Ø 1.8mm, with suction-regulator and 4mm Luer connection, reusable
Primary DI / UDI-DI
04055207040089
FDA Product Code
GEA
GMDN Term
General-purpose endoscopic needle, reusable
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 4.7 Millimeter
Length — 320 Millimeter

Other devices from Richard Wolf GmbH

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Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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