Catalog Number

-

Brand Name

PharmChem, Inc. Transparent Overlay Film with Cutout

Version/Model Number

Single Overlay

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

d23d6a7b-7cba-4d07-a3ec-91bc983f3387

Public Version Date

September 09, 2019

Public Version Number

1

DI Record Publish Date

August 31, 2019

Package DI Number

10860001701064

Quantity per Package

14

Contains DI Package

00860001701067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Case