Catalog Number

80010

Brand Name

CONVERTORS

Version/Model Number

80010

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

KKX

Product Code Name

Drape, surgical

Public Device Record Key

8e8e58e0-e532-4d5b-8111-f05c8564ccb2

Public Version Date

July 17, 2018

Public Version Number

3

DI Record Publish Date

July 13, 2016

Package DI Number

50630140162556

Quantity per Package

6

Contains DI Package

00630140162551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE