Catalog Number

-

Brand Name

Surgipoint

Version/Model Number

698BKC

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

b9649db0-cb23-458e-a1d6-b31d3ef3065a

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

December 07, 2017

Package DI Number

10812444027423

Quantity per Package

12

Contains DI Package

00812444027426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-