Duns Number:536935331
Device Description: The holder is used to hold the plate and ease the handling during surgery.
Catalog Number
-
Brand Name
B-BOP®
Version/Model Number
189202ND
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 22, 2018
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
-
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
KIL
Product Code Name
POSITIONER, SOCKET
Public Device Record Key
84ed7c43-be30-42bb-b75f-84ef70662837
Public Version Date
April 21, 2021
Public Version Number
6
DI Record Publish Date
May 26, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |