Catalog Number

103100

Brand Name

DermAssist®

Version/Model Number

Sterile Singles, Latex Exam

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)

Yes

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

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

bf85677f-eed6-4c3e-8818-f95897e421a6

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Package DI Number

20813172021056

Quantity per Package

4

Contains DI Package

10813172021059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

100/bx, 4 bx/cs