Vascular Probe Extra Supple - The Vascular Probe is a sterile, single use, - SYNOVIS LIFE TECHNOLOGIES, INC.

Duns Number:017415781

Device Description: The Vascular Probe is a sterile, single use, disposable polymeric device with a streamline The Vascular Probe is a sterile, single use, disposable polymeric device with a streamline bulb on each end of a flexible shaft. The bulbs are of different size on each end of the Vascular Probe.

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More Product Details

Catalog Number

7081520ES

Brand Name

Vascular Probe Extra Supple

Version/Model Number

7081520ES

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

K130896,K130896

Product Code Details

Product Code

DWP

Product Code Name

DILATOR, VESSEL, SURGICAL

Device Record Status

Public Device Record Key

1d8a74b1-5298-4ec4-adcb-99ae91862415

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

50085412532627

Quantity per Package

5

Contains DI Package

00085412532622

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"SYNOVIS LIFE 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. 135