Duns Number:081224143
Device Description: ONE (1) PACKAGE - CONTAINING 0.5cc
Catalog Number
-
Brand Name
DBM Putty 0.5cc
Version/Model Number
BM895005
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
Yes
FDA Premarket Submission
K130498
Product Code
MBP
Product Code Name
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Public Device Record Key
5049f0d6-f674-4b63-9aab-23af94d659ff
Public Version Date
June 16, 2021
Public Version Number
2
DI Record Publish Date
August 05, 2019
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 | 1719 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3162 |
| U | Unclassified | 25 |