Jigsaw Medical, LLC - Wound Dressing - JIGSAW MEDICAL, LLC

Duns Number:079233827

Device Description: Wound Dressing

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More Product Details

Catalog Number

TD1310

Brand Name

Jigsaw Medical, LLC

Version/Model Number

TD1310

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Device Record Status

Public Device Record Key

91d19eb0-1e50-46c6-8eaa-d7bc02c0dd28

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

September 25, 2019

Additional Identifiers

Package DI Number

00856274008385

Quantity per Package

10

Contains DI Package

00856274008378

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"JIGSAW MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23