Duns Number:830350380
Device Description: WEDGE 60000215INT PLEXUR P 40MMX15MMX15
Catalog Number
-
Brand Name
PLEXUR P®
Version/Model Number
60000215INT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
MQV
Product Code Name
FILLER, BONE VOID, CALCIUM COMPOUND
Public Device Record Key
8a8f8d50-37b8-47d1-90a8-53479c962174
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 02, 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 |
|---|---|---|
| 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 |