Catalog Number

-

Brand Name

Surgipoint

Version/Model Number

V488

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K120556,K120556

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

14aa7a32-8111-41c0-a2d0-a1c3515ccd6d

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

November 21, 2018

Package DI Number

10812444028970

Quantity per Package

12

Contains DI Package

00812444028973

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-