Duns Number:961832156
Device Description: Biopsy Site Identifier
Catalog Number
-
Brand Name
Mammotome CORMARK
Version/Model Number
MAM3015
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082278,K082278
Product Code
FZP
Product Code Name
Clip, Implantable
Public Device Record Key
fb5ce5b0-e33e-4f30-b027-0ddc37b14a92
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
November 01, 2016
Package DI Number
10841911100468
Quantity per Package
10
Contains DI Package
00841911100461
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 | 17 |
2 | A medical device with a moderate to high risk that requires special controls. | 186 |