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Kerasave Ker 001-00

by Al.Chi.Mi.A

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 Number08021118001408 UDI-DI Date5 Dec 2022ListedStatusListed 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  • Withdrawn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
Kerasave
Generic Name
Corneal storage medium
Model / Reference
KER 001-00
Primary DI / UDI-DI
08021118001408
De Novo Number
FDA Product Code
QCW
GMDN Term
Corneal storage medium
Device Class
Class II
Regulation Number
886.4320
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 20 Milliliter

Related devices

Category: Corneal storage medium

Similar devices

Also classified as Corneal storage medium.

Other devices from Al.Chi.Mi.A

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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