Catalog Number

OM-9043

Brand Name

MAGNUMWIRE

Version/Model Number

OM-9043

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

K070673,K070673

Product Code

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Public Device Record Key

1f58000c-c6da-4ce8-b296-e99492846ed6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 13, 2017

Package DI Number

20817470007279

Quantity per Package

12

Contains DI Package

00817470007275

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX