Catalog Number

C-079.03.000

Brand Name

COMBINATION CASE

Version/Model Number

C-079.03.000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 22, 2020

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ETF

Product Code Name

UNIT, EXAMINING/TREATMENT, ENT

Public Device Record Key

981a8526-b194-44b7-b362-203531286a94

Public Version Date

December 23, 2020

Public Version Number

2

DI Record Publish Date

September 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-