Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 60-3200-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

OEA

Product Code Name

Non-surgical isolation gown

Public Device Record Key

0fb7ab96-e0c5-45c1-bb6b-ab402f3af57a

Public Version Date

February 12, 2021

Public Version Number

1

DI Record Publish Date

February 04, 2021

Package DI Number

26931918159260

Quantity per Package

60

Contains DI Package

16931918159263

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton