Catalog Number

150703-CRE

Brand Name

BLUESTITCH

Version/Model Number

IPN028393

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

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Public Device Record Key

a1cd7c7e-fd7a-43fd-a484-fbb9e260fd4e

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

February 13, 2018

Package DI Number

24026704626506

Quantity per Package

12

Contains DI Package

14026704626509

Package Discontinue Date

January 15, 2019

Package Status

Not in Commercial Distribution

Package Type

Box