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Ultrasonic Gastrovideoscope Olympus Gf Type UE160-AL5 Gf-UE160-AL5

by Olympus Medical Systems Corporation

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 Number04953170467349 UDI-DI Date25 Sep 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  • Withdrawn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
Ultrasonic Gastrovideoscope Olympus Gf Type UE160-AL5
Generic Name
Flexible ultrasound gastroduodenoscope
Model / Ref / Catalog
GF-UE160-AL5, N5366840
Primary DI / UDI-DI
04953170467349
FDA Product Code
FDF, ITX
GMDN Term
Flexible ultrasound gastroduodenoscope
Device Class
Class II
Regulation Number
876.1500, 892.1570
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Other devices from Olympus Medical Systems Corporation

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Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No