Catalog Number

M962P20XL

Brand Name

MEDADV

Version/Model Number

M962P20XL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

DXC

Product Code Name

Clamp, Vascular

Public Device Record Key

c56de9cf-f06b-42cd-87b5-5ac5fcbba41f

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 11, 2018

Package DI Number

10819667020798

Quantity per Package

10

Contains DI Package

00819667020791

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-