Catalog Number

G0617814

Brand Name

Steelex

Version/Model Number

G0617814

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

GAQ

Product Code Name

SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE

Public Device Record Key

19561d16-d2d0-46d9-a29c-6219d92133c0

Public Version Date

October 11, 2022

Public Version Number

7

DI Record Publish Date

August 20, 2015

Package DI Number

04046964272639

Quantity per Package

12

Contains DI Package

04038653911097

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton