Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 90-2040-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

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

c7f7bd5b-6fa3-441d-9279-db8266618f2c

Public Version Date

December 27, 2021

Public Version Number

3

DI Record Publish Date

February 02, 2021

Package DI Number

26931918172474

Quantity per Package

22

Contains DI Package

16931918172477

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton