Catalog Number

GBS0501

Brand Name

SKIN TEST

Version/Model Number

0.3cc

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

P020012,P020012,P020012

Product Code

LMH

Product Code Name

Implant, Dermal, For Aesthetic Use

Public Device Record Key

ca26e21a-0bc2-4978-bb88-19f747ae5554

Public Version Date

September 14, 2022

Public Version Number

3

DI Record Publish Date

March 19, 2019

Package DI Number

10350224000032

Quantity per Package

5

Contains DI Package

00350224000035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton