Catalog Number

URS-10T

Brand Name

Healgen

Version/Model Number

URS-10T

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

-

Product Code Name

-

Public Device Record Key

a81005ca-5c6c-41d1-a8aa-1bbcf420ddd9

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

December 20, 2019

Package DI Number

20816490024327

Quantity per Package

100

Contains DI Package

10816490024320

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case