Duns Number:051437143
Catalog Number
-
Brand Name
N/A
Version/Model Number
3-C-1H2-12X20
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 08, 2020
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEA
Product Code Name
Cannula, Surgical, General & Plastic Surgery
Public Device Record Key
ac8e7b6b-cb07-4d8c-bd3f-8e4f7c4b3795
Public Version Date
October 09, 2020
Public Version Number
2
DI Record Publish Date
January 25, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 567 |
2 | A medical device with a moderate to high risk that requires special controls. | 13 |