MEDADV - PRESS RADIAL ARTERY TOURNIQUET SIZE MEDIUM - MEDAS INC

Duns Number:080593067

Device Description: PRESS RADIAL ARTERY TOURNIQUET SIZE MEDIUM

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More Product Details

Catalog Number

M962P20

Brand Name

MEDADV

Version/Model Number

M962P20

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"

Yes

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

K142359,K142359

Product Code Details

Product Code

DXC

Product Code Name

Clamp, Vascular

Device Record Status

Public Device Record Key

1a06e42b-bd21-4a12-9ec5-b2aaeadf87b0

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 11, 2018

Additional Identifiers

Package DI Number

10819667020804

Quantity per Package

10

Contains DI Package

00819667020807

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDAS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 40