Duns Number:121622872
Device Description: RAN-11125NBB, F/GPN 74269-01M
Catalog Number
RAN-11125NBB
Brand Name
RAN-11125NBB, F/G
Version/Model Number
11 Gauge x 125mm
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
K131157,K131157,K131157,K131157,K131157
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
e9ccccd9-c7c9-4fe3-8c70-ee378807a091
Public Version Date
July 30, 2020
Public Version Number
4
DI Record Publish Date
May 08, 2017
Package DI Number
20858690006062
Quantity per Package
30
Contains DI Package
10858690006065
Package Discontinue Date
July 21, 2020
Package Status
Not in Commercial Distribution
Package Type
Case
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 |