Catalog Number

3910-900-017

Brand Name

XBraid

Version/Model Number

3910-900-017

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Public Device Record Key

9c8aa586-0b24-4352-bc4c-ba6da641cff7

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

November 19, 2015

Package DI Number

37613327261500

Quantity per Package

12

Contains DI Package

07613327261509

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack