Sterile Disposable Endocavity Needle Guide Kit - Sterile Disposable Endocavity Needle Guide Kit - PROTEK MEDICAL PRODUCTS, INC.

Duns Number:965417181

Device Description: Sterile Disposable Endocavity Needle Guide Kit for use with Toshiba PVF-621VT, PVF-641VT, Sterile Disposable Endocavity Needle Guide Kit for use with Toshiba PVF-621VT, PVF-641VT, PVF-651VT, PVG-601V, PVM-651VT, PVN-661VT, PVT-661VT & PVQ-641V and Siemens EC9-4 (Acuson S2000™ & Sonoline Antares™ Ultrasound Systems) Ultrasound Transducers

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More Product Details

Catalog Number

5533

Brand Name

Sterile Disposable Endocavity Needle Guide Kit

Version/Model Number

5533

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K970893,K971115,K971722,K970893,K971115,K971722

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

181a9a15-052f-41f4-a049-06cc7b4b1c36

Public Version Date

June 17, 2022

Public Version Number

9

DI Record Publish Date

November 03, 2017

Additional Identifiers

Package DI Number

10841912105325

Quantity per Package

24

Contains DI Package

00841912105328

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PROTEK MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 451