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Exact Medical Manufacturing, Inc. MM5003

by Exact Medical Manufacturing

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number06975424198715 UDI-DI Date29 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1907-2021 FDA Class II initiated 29 Apr 2021 on shared 510(k) K101689

    No 510k for the product to be used in a natural or surgical opening to the body

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Exact Medical Manufacturing, Inc.
Generic Name
Medical equipment/instrument drape, single-use
Model / Ref / Catalog
MM5003
Primary DI / UDI-DI
06975424198715
510(k) Number
FDA Product Code
KKX
GMDN Term
Medical equipment/instrument drape, single-use
Device Class
Class II
Regulation Number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K101689)

Show all (12)

Other devices from Exact Medical Manufacturing

See all devices from Exact Medical Manufacturing →

Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No