Duns Number:184763290
Catalog Number
CORC1615/A
Brand Name
CorVocet™
Version/Model Number
00884450333358
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCG
Product Code Name
Biopsy needle
Public Device Record Key
0db3245f-9f2a-4599-a640-215650e76773
Public Version Date
November 01, 2021
Public Version Number
2
DI Record Publish Date
November 06, 2018
Package DI Number
10884450333355
Quantity per Package
5
Contains DI Package
00884450333358
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 | 573 |
2 | A medical device with a moderate to high risk that requires special controls. | 8779 |