Duns Number:002348191
Device Description: BONE WAX 2.5 GRAMS
Catalog Number
BW-102
Brand Name
DEKNATEL
Version/Model Number
IPN011157
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 04, 2018
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
MTJ
Product Code Name
WAX,BONE
Public Device Record Key
651c54cd-0143-41a3-b1ad-53c45eb1cbce
Public Version Date
January 08, 2020
Public Version Number
3
DI Record Publish Date
October 16, 2015
Package DI Number
24026704590470
Quantity per Package
12
Contains DI Package
04026704590476
Package Discontinue Date
October 04, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |