Catalog Number

V-3813

Brand Name

DEKNATEL

Version/Model Number

IPN026647

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

OVN

Product Code Name

Suture kit

Public Device Record Key

de1e0cdc-a0bf-4109-9333-c7bf735d039d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 16, 2015

Package DI Number

24026704555387

Quantity per Package

6

Contains DI Package

04026704555383

Package Discontinue Date

March 09, 2018

Package Status

Not in Commercial Distribution

Package Type

Box