Catalog Number

-

Brand Name

Degania

Version/Model Number

231131080DS

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

-

Product Code

DXC

Product Code Name

Clamp, Vascular

Public Device Record Key

82ab75e5-ada4-4ba9-be80-a7fdcfcbd8d4

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

January 09, 2019

Package DI Number

47290001603053

Quantity per Package

10

Contains DI Package

27290001603059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton