Catalog Number

42-3100

Brand Name

NA

Version/Model Number

42-3100

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"

-

For Single-Use

Yes

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

30a7de04-74c4-4ac3-b872-6f952f6280ad

Public Version Date

August 20, 2018

Public Version Number

1

DI Record Publish Date

July 18, 2018

Package DI Number

50885403076051

Quantity per Package

10

Contains DI Package

10885403076053

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case