Catalog Number

80010

Brand Name

CONVERTORS

Version/Model Number

80010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 26, 2024

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

88b4df22-8eeb-4a0b-bfb1-4daa4b96eed7

Public Version Date

January 14, 2022

Public Version Number

7

DI Record Publish Date

November 13, 2017

Package DI Number

50885380151246

Quantity per Package

6

Contains DI Package

10885380151248

Package Discontinue Date

November 26, 2024

Package Status

In Commercial Distribution

Package Type

CASE