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Probe Cover Kits 2243

by Protek Medical Products, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10841912102973 UDI-DIDate16 Sep 2016ListedStatusListed 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  • Withdrawn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
Probe Cover Kits
Generic Name
Body-surface ultrasound imaging transducer cover
Model / Reference
2243
Primary DI / UDI-DI
10841912102973
510(k) Number
FDA Product Code
KKX
GMDN Term
Body-surface ultrasound imaging transducer cover
Device Class
Class II
Regulation Number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Body-surface ultrasound imaging transducer cover

Cleared under the same submission (K970893)

Show all (12)

Other devices from Protek Medical Products, Inc.

See all devices from Protek Medical Products, Inc. →

Properties

  • Single Use
  • Lot / Batch Number

Other properties (12)

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