PROTEK MEDICAL PRODUCTS, INC.

Address:4125 WESTCOR COURT,CORALVILLE,IA,52241,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Transducer, Ultrasonic, Diagnostic (ITX) (7) Drape, Surgical (KKX) (3)

Premarket Exempt

Clear

Disposable Needle Guide - 10841912104908 Catalog Number :

Device Class :

Duns Number: 965417181

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 250

Disposable Needle Guide - 10841912104915 Catalog Number :

Device Class :

Duns Number: 965417181

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 250

Disposable Needle Guide - 10841912104922 Catalog Number :

Device Class :

Duns Number: 965417181

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 250

Disposable Needle Guide - 10841912104939 Catalog Number :

Device Class :

Duns Number: 965417181

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 250

Reusable Stainless Steel Endocavity Needle Guide - 10841912105226 Catalog Number :

Device Description : Stainless Steel Reusable Endocavity Needle Guide for GE RIC5-9-D, RIC5-9H, RIC5- Stainless Steel Reusable Endocavity Needle Guide for GE RIC5-9-D, RIC5-9H, RIC5-9W-D, RIC5-9W-RS, & RIC6-12-D, Mindray DE10-3U and Samsung Medison V5-9 Ultrasound Transducers

Device Class : 2

Duns Number: 965417181

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Reusable Stainless Steel Endocavity Needle Guide - 10841912105257 Catalog Number : 6550

Device Description : Stainless Steel Reusable Endocavity Needle Guide for Toshiba PVT-781VT, PVU-781V Stainless Steel Reusable Endocavity Needle Guide for Toshiba PVT-781VT, PVU-781VT & 11C3 Ultrasound Transducers

Device Class : 2

Duns Number: 965417181

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Probe Cover Kits - 10841912105424 Catalog Number :

Device Class :

Duns Number: 965417181

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 250

Disposable Needle Guide - 10841912105455 Catalog Number :

Device Class :

Duns Number: 965417181

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 250

SlimFit Non-Sterile Endocavity Probe Covers - 10841912105486 Catalog Number : 2517

Device Class :

Duns Number: 965417181

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 24

Probe Covers - 10841912105509 Catalog Number : D101713-001

Device Class :

Duns Number: 965417181

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 100

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