Catalog Number

BT80110-7C

Brand Name

A Plus

Version/Model Number

1

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"

Yes

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

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

7b088d42-9c34-437d-905d-043cd89ec01d

Public Version Date

August 11, 2020

Public Version Number

1

DI Record Publish Date

August 03, 2020

Package DI Number

80683534210112

Quantity per Package

240

Contains DI Package

00683534210116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case