Catalog Number

PK52218

Brand Name

Jigsaw Medical,LLC

Version/Model Number

PK52218

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OXQ

Product Code Name

Dressing Change Tray

Public Device Record Key

16a09bae-5ee6-4990-8001-1cdec2225e47

Public Version Date

September 30, 2019

Public Version Number

1

DI Record Publish Date

September 20, 2019

Package DI Number

00856274008057

Quantity per Package

20

Contains DI Package

00856274008026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case