3CRF V Nav Sensor Holder 6080

by Protek Medical Products, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10841912101938 UDI-DI	Date16 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: 3CRF V Nav Sensor Holder
Generic Name: Ultrasound imaging system tracking positioner, reusable
Model / Reference: 6080

Primary DI / UDI-DI: 10841912101938
510(k) Number: K973958
FDA Product Code: ITX
GMDN Term: Ultrasound imaging system tracking positioner, reusable

Device Class: Class II
Regulation Number: 892.1570
GUDID distribution status: In Commercial Distribution

Sterilization Method: High-level Disinfectant

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Properties

Prescription Use
Lot / Batch Number

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: 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