Catalog Number
BW25G
Brand Name
Bone Wax
Version/Model Number
BW25G
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K024372,K024372
Product Code
MTJ
Product Code Name
WAX,BONE
Public Device Record Key
cffece2d-7c17-4e33-912c-fb52feee5155
Public Version Date
August 09, 2018
Public Version Number
4
DI Record Publish Date
August 31, 2015
Package DI Number
20884521196268
Quantity per Package
12
Contains DI Package
10884521196261
Package Discontinue Date
-
Package Status
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 | 132 |
2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
3 | A medical device with high risk that requires premarket approval | 202 |
U | Unclassified | 40 |