Catalog Number

91512

Brand Name

Clever Medical

Version/Model Number

91512

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

K101598,K101598

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

cd116062-f29a-4cd9-958e-390ab288fb37

Public Version Date

November 08, 2018

Public Version Number

4

DI Record Publish Date

September 10, 2016

Package DI Number

00862062000318

Quantity per Package

1

Contains DI Package

00862062000301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-