SPINR - Distal Access torque devices are used to maneuver - ZIEN MEDICAL TECHNOLOGIES, INC.

Duns Number:017535668

Device Description: Distal Access torque devices are used to maneuver guidewires in the coronary and periphera Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature

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More Product Details

Catalog Number

5X-GW

Brand Name

SPINR

Version/Model Number

5X-GW

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K141054,K141054,K141054

Product Code Details

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Device Record Status

Public Device Record Key

6c3085a9-d1b7-4cdf-a973-c8e8544044ab

Public Version Date

July 29, 2022

Public Version Number

1

DI Record Publish Date

July 21, 2022

Additional Identifiers

Package DI Number

B0905XGW1

Quantity per Package

5

Contains DI Package

B0905XGW0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Carton

"ZIEN MEDICAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24