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Orise™ M00519540

by Boston Scientific

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08714729974635 UDI-DI Date5 Mar 2018ListedStatusListed 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  • Withdrawn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
Orise™
Generic Name
Multichannel gastrointestinal endoscopic guide, non-steerable
Model / Reference
M00519540
Primary DI / UDI-DI
08714729974635
FDA Product Code
FED, ODB, GAD
GMDN Term
Multichannel gastrointestinal endoscopic guide, non-steerable
Device Class
Class II
Regulation Number
876.1500, 878.4800
GUDID distribution status
Not in Commercial Distribution

Other devices from Boston Scientific

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Properties

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

Other properties (10)

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