Catalog Number

B7916N

Brand Name

Sharpoint Plus 6-0 PLAIN GUT 18"/45CM PC-1

Version/Model Number

B7916N

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

GAL

Product Code Name

SUTURE, ABSORBABLE, NATURAL

Public Device Record Key

dca2e6f1-5ae0-4a38-9b4e-071d72bc60a7

Public Version Date

April 01, 2021

Public Version Number

1

DI Record Publish Date

March 24, 2021

Package DI Number

10848782033871

Quantity per Package

12

Contains DI Package

00848782033874

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box