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OcuCool ODM-E01

by RecensMedical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number08800073100124 UDI-DI Date19 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
OcuCool
Generic Name
Ophthalmic injector/illuminating catheter
Model / Reference
ODM-E01
Primary DI / UDI-DI
08800073100124
De Novo Number
FDA Product Code
QZQ
GMDN Term
Ophthalmic injector/illuminating catheter
GUDID distribution status
In Commercial Distribution

Other devices from RecensMedical, Inc.

  • TargetCool-e RH-PD06W

    Class II

  • OcuCool

    Not classified

  • CryoVIVE

    Class II

  • TargetCool (RM-DT02W)

    Class IIa

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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