Catalog Number

4701

Brand Name

SharpShooter® Surgical Suture

Version/Model Number

4701

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2016

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

c7ab622b-3bf8-4aa2-a94a-db1c46dde814

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 24, 2015

Package DI Number

M92847012

Quantity per Package

10

Contains DI Package

M92847011

Package Discontinue Date

June 30, 2016

Package Status

Not in Commercial Distribution

Package Type

Carton