Duns Number:600007082
Device Description: Identi Loops Maxi White 18" sterile
Catalog Number
-
Brand Name
Degania
Version/Model Number
231141080DS
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
5a3bd6b3-c06d-4c57-9cf1-b63c2461a788
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
January 09, 2019
Package DI Number
47290001603060
Quantity per Package
10
Contains DI Package
27290001603066
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 20 |