Catalog Number

-

Brand Name

Sharpoint Plus

Version/Model Number

917BB

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GAR

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Public Device Record Key

9728336c-a8a4-43a3-9962-78d2cc63c186

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

April 01, 2019

Package DI Number

10848782033291

Quantity per Package

100

Contains DI Package

00848782033294

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag