Catalog Number

-

Brand Name

V.A.T.S Foerster Debakey Clamp

Version/Model Number

2601-8245

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

-

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

K152400

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

a0d63447-141f-4435-b429-e78f08d4fa72

Public Version Date

March 03, 2022

Public Version Number

1

DI Record Publish Date

February 23, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-