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Vyse HC9R

by Caelaris Medtech, Inc.

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 Number00850090590468 UDI-DI Date31 Aug 2026ListedStatusListed 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  • Withdrawn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
Vyse
Generic Name
Gastrointestinal endoscopic clip, short-term
Model / Reference
HC9R
Primary DI / UDI-DI
00850090590468
FDA Product Code
PKL
GMDN Term
Gastrointestinal endoscopic clip, short-term
Device Class
Class II
Regulation Number
876.4400
GUDID distribution status
In Commercial Distribution

Other devices from Caelaris Medtech, Inc.

See all devices from Caelaris Medtech, Inc. →

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