PullUp Probe Cover Kit 2097

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	Number00841912100170 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Withdrawn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: PullUp Probe Cover Kit
Generic Name: Body-surface ultrasound imaging transducer cover
Model / Ref / Catalog: 2097, 2097ME

Primary DI / UDI-DI: 00841912100170
510(k) Number: K970893
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

Other devices from Protek Medical Products, Inc.

Sterile Single-Use Probe Cover Kit 1090

Class II
Sterile Disposable Endocavity Needle Guide Kit 5253

Class II
Biopsy Starter Kit 7257

Not classified
Reusable Multi Angle Biospy Bracket 6158

Class II
Biopsy Starter Kit 7138

Not classified
Sterile Disposable Endocavity Needle Guide Kit 5176

Class II

See all devices from Protek Medical Products, Inc. →

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