Duns Number:801089152
Device Description: OsteoSurge 300 Putty, 1cc - demineralized human bone mixed with poloxamer resorbable reve OsteoSurge 300 Putty, 1cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package.
Catalog Number
56500010
Brand Name
OsteoSurge 300 Putty
Version/Model Number
56500010
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)
Yes
FDA Premarket Submission
K061880,K103742
Product Code
MBP
Product Code Name
Filler, bone void, osteoinduction (w/o human growth factor)
Public Device Record Key
674f8f7f-3a61-4adb-a017-9b05610dffa1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 21, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |