Probe Cover Kit 1460

by Protek Medical Products, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841912100729 UDI-DI	Date16 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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Withdrawn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: 1460, ACC-1460

Primary DI / UDI-DI: 00841912100729
510(k) Number: K970889
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

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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