Catalog Number

-

Brand Name

GelShot

Version/Model Number

GSA2RM1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 26, 2019

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

MUI

Product Code Name

Media,Coupling,Ultrasound

Public Device Record Key

7bca44af-3314-4f76-ad02-e06875bb86b2

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-