Catalog Number

-

Brand Name

SURGIPOINT

Version/Model Number

P8601

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

-

Product Code

GAW

Product Code Name

Suture, Nonabsorbable, Synthetic, Polypropylene

Public Device Record Key

c2803c29-a178-4a74-b72b-1f1271d136eb

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

November 17, 2016

Package DI Number

10812444026082

Quantity per Package

12

Contains DI Package

00812444026085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-