Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 90-3831-S2

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

K102652,K102652,K102652

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

f167915b-affe-4775-a233-6d6e08bfaa91

Public Version Date

December 27, 2021

Public Version Number

3

DI Record Publish Date

February 09, 2021

Package DI Number

36931918176165

Quantity per Package

22

Contains DI Package

26931918176168

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case