Catalog Number

X-4852

Brand Name

DEKNATEL

Version/Model Number

IPN026934

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"

Yes

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

7d82d84e-6945-4dc9-bafa-e1a267076106

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

March 09, 2018

Package DI Number

14026704427069

Quantity per Package

12

Contains DI Package

34026704427063

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box