Duns Number:830350380
Device Description: GRANULES 60000010 PLEXUR P 10CC
Catalog Number
-
Brand Name
PLEXUR P®
Version/Model Number
60000010
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 08, 2018
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K080511
Product Code
MBP
Product Code Name
Filler, bone void, osteoinduction (w/o human growth factor)
Public Device Record Key
9ebd9bee-b673-4b5a-8ef2-8651fa6c0df1
Public Version Date
February 21, 2019
Public Version Number
4
DI Record Publish Date
July 20, 2015
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 | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |