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ORIGIO Gradient 100 84000060M

by CooperSurgical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

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 Number00888937029352 UDI-DI Date5 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-3298-2024 FDA Class II initiated 16 Feb 2024
    • Ongoing Z-3297-2024 FDA Class II initiated 16 Feb 2024
    • Ongoing Z-3296-2024 FDA Class II initiated 16 Feb 2024

    Low concentration of sodium pyruvate in the wash could compromise gamete development

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ORIGIO Gradient 100
Generic Name
IVF medium
Model / Reference
84000060M
Primary DI / UDI-DI
00888937029352
510(k) Number
FDA Product Code
MQL
GMDN Term
IVF medium
Device Class
Class II
Regulation Number
884.6180
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K153267)

Show all (12)

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

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

Other properties (10)

  • Single Use: 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
  • Manufacturing Date: No