Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 90-2020-W1-HB

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

b3873e9b-8939-456b-bc96-da2b3a6b716c

Public Version Date

December 27, 2021

Public Version Number

2

DI Record Publish Date

April 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-