Duns Number:079233827
Device Description: Wound Dressing
Catalog Number
TD0605
Brand Name
Jigsaw Medical, LLC
Version/Model Number
TD0605
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
7ed30a2d-e100-4d0f-8a73-78b3d7cb1cd9
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
September 25, 2019
Package DI Number
00856274008446
Quantity per Package
25
Contains DI Package
00856274008439
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 23 |