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Probe Cover Kit 1241

by Protek Medical Products, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841912104574 UDI-DIDate23 Sep 2016ListedStatusListed 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  • Withdrawn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 22 Oct 2026.

Specification

GUDID

Trade Name
Probe Cover Kit
Generic Name
Body-surface ultrasound imaging transducer cover
Model / Ref / Catalog
1241
Primary DI / UDI-DI
00841912104574
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 (K970889)

Show all (12)

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Properties

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

Other properties (9)

  • 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