Duns Number:121622872
Device Description: Cervos 15GA X 60MM Delivery CannulaP/N: 74359-01MCustomer #: 12153
Catalog Number
CER-SUB-1560
Brand Name
CER-SUB-1560
Version/Model Number
15GA X 60MM
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
FGY
Product Code Name
Cannula, Injection
Public Device Record Key
8dae3e5b-014b-4484-8834-2384ad5fc88d
Public Version Date
May 10, 2021
Public Version Number
1
DI Record Publish Date
May 01, 2021
Package DI Number
10850023741056
Quantity per Package
1
Contains DI Package
00850023741059
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 93 |