Duns Number:042763706
Device Description: OUSIA bioPLUG 10MM X 20MM 10/BOX
Catalog Number
OUSPGS
Brand Name
OUSIA bioPLUG
Version/Model Number
OUSPGS
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)
-
FDA Premarket Submission
-
Product Code
LYC
Product Code Name
Bone grafting material, synthetic
Public Device Record Key
76193b10-6cfd-4e5b-8258-7b16d7fea1a1
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
October 24, 2015
Package DI Number
10614950007803
Quantity per Package
10
Contains DI Package
00614950007806
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvec Tray
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1288 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 943 |
| U | Unclassified | 6 |