Catalog Number

-

Brand Name

Soterixmedical HD-Gel

Version/Model Number

15-0135

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GYB

Product Code Name

Media, Electroconductive

Public Device Record Key

2d33845f-07ef-461f-8bb4-9be9bf46f853

Public Version Date

November 30, 2021

Public Version Number

1

DI Record Publish Date

November 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-