Duns Number:121622872
Device Description: CER-BN-84PN: 74361-01M
Catalog Number
CER-BN-84
Brand Name
CER-BN-84
Version/Model Number
8 GA X 4 IN
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
K983187,K983187,K983187
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
4dc1a575-6d33-49c9-9fef-e1e289fa519c
Public Version Date
October 22, 2021
Public Version Number
1
DI Record Publish Date
October 14, 2021
Package DI Number
10850023741315
Quantity per Package
1
Contains DI Package
00850023741318
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 |