Catalog Number

-

Brand Name

SharpShooter Surgical Suture

Version/Model Number

PB4704

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

GAS

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyester

Public Device Record Key

d9fc0ddd-774d-4fab-bc9e-0881cdf105c3

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

August 15, 2018

Package DI Number

10812444028314

Quantity per Package

10

Contains DI Package

00812444028317

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-