Catalog Number

TD3012

Brand Name

Jigsaw Medical, LLC

Version/Model Number

TD3012

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

35007727-410f-46c7-8ea2-c927379d72cf

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

September 25, 2019

Package DI Number

00856274008330

Quantity per Package

10

Contains DI Package

00856274008323

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case