Duns Number:928308407
Device Description: Single Needle Diamond Wire
Catalog Number
-
Brand Name
Diamond Wire
Version/Model Number
IM-DW
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GDI
Product Code Name
Dissector, Surgical, General & Plastic Surgery
Public Device Record Key
622f0595-e55a-4a74-94cb-56d2eb0e9e71
Public Version Date
July 27, 2018
Public Version Number
1
DI Record Publish Date
June 26, 2018
Package DI Number
10851314007226
Quantity per Package
2
Contains DI Package
00851314007229
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 13 |