Duns Number:071595540
Device Description: BIOPSY CHANNEL ACCESORY INTRODUCERS
Catalog Number
000160
Brand Name
NA
Version/Model Number
000160
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
-
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
fc66c95f-ccf7-45c9-8ed8-9db9019a8b85
Public Version Date
October 13, 2021
Public Version Number
1
DI Record Publish Date
October 05, 2021
Package DI Number
20653405054082
Quantity per Package
1
Contains DI Package
10653405054085
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1412 |
2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
3 | A medical device with high risk that requires premarket approval | 95 |