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Probe Cover Kits 2450

by Protek Medical Products, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10841912106339 UDI-DIDate13 Mar 2020ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Probe Cover Kits
Generic Name
Body-surface ultrasound imaging transducer cover
Model / Reference
2450
Primary DI / UDI-DI
10841912106339
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)

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Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • 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
  • Manufacturing Date: No