Catalog Number

7210915

Brand Name

ULTRABRAID

Version/Model Number

7210915

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

K041216,K041216

Product Code

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Public Device Record Key

6be56fe4-8440-46a3-a543-5f75962937cb

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

August 30, 2015

Package DI Number

23596010511939

Quantity per Package

10

Contains DI Package

03596010511935

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX