Catalog Number

-

Brand Name

INNOSET

Version/Model Number

596121

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

b97b31a5-8dbc-4be3-abca-c4c687d20b42

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

June 06, 2016

Package DI Number

20857182006009

Quantity per Package

4

Contains DI Package

10857182006002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE