Catalog Number

48256NS

Brand Name

CONVERTORS

Version/Model Number

48256NS

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

PUI

Product Code Name

Drape, surgical, exempt

Public Device Record Key

3e53fd67-eccf-49f2-b1c6-a6d627e51894

Public Version Date

May 16, 2019

Public Version Number

1

DI Record Publish Date

May 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-