Catalog Number

8201

Brand Name

MEDICOM SAFEBASICS

Version/Model Number

8201

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

0ffb5919-d55d-4fff-96d5-85d46bf58324

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

August 06, 2018

Package DI Number

20686864049788

Quantity per Package

6

Contains DI Package

12686864049789

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTERCASE