Catalog Number

-

Brand Name

PharmChem, Inc. Transparent Overlay Film with Cutout

Version/Model Number

Single Overlay - Rev. 3

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

PYO

Product Code Name

Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

Public Device Record Key

5b1cb29e-c3a0-4274-93b0-0aa5e222c7c1

Public Version Date

September 03, 2021

Public Version Number

1

DI Record Publish Date

August 26, 2021

Package DI Number

00860002279626

Quantity per Package

25

Contains DI Package

00860001701098

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box