Catalog Number

G2N99397

Brand Name

GEN2

Version/Model Number

G2N99397

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"

-

For Single-Use

-

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

K120492

Product Code

DXC

Product Code Name

Clamp, Vascular

Public Device Record Key

100f51aa-802c-435e-a3ea-fed7b8ceb51f

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-