Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 80-05170G-S

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)

-

Over the Counter (OTC)

-

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

3d360a01-4df6-4f6c-a02a-d6ef6e97826f

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

February 04, 2021

Package DI Number

26931918182145

Quantity per Package

13

Contains DI Package

16931918182148

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton