Catalog Number

59413

Brand Name

CONVERTORS

Version/Model Number

59413

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

2f7b18f4-28d2-4999-a969-1dfad3f4a2fa

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

July 13, 2016

Package DI Number

50630140930513

Quantity per Package

6

Contains DI Package

00630140018810

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE