Catalog Number

H7-100C6K

Brand Name

DEKNATEL

Version/Model Number

IPN012767

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

K001440,K001440,K001440

Product Code

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Public Device Record Key

3016c917-7a9c-4c3b-8e46-a590f8ae6390

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 16, 2015

Package DI Number

24026704416602

Quantity per Package

1

Contains DI Package

04026704416608

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sleeve