Catalog Number

-

Brand Name

Sharpoint Plus

Version/Model Number

R358N

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

NEW

Product Code Name

SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Public Device Record Key

e4847d59-04a1-4089-b20f-3bccca48e476

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

June 16, 2019

Package DI Number

10848782031075

Quantity per Package

12

Contains DI Package

00848782031078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box