Duns Number:042763706
Device Description: OUSIA bioADAPT 15x20MM RESORBABLE DENTAL MEMBRANE 25/BOX
Catalog Number
OUSB1
Brand Name
OUSIA bioADAPT
Version/Model Number
OUSB1
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
NPL
Product Code Name
Barrier, animal source, intraoral
Public Device Record Key
9cf98bbb-b10c-47ca-9c4c-c52576fc412b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 24, 2015
Package DI Number
10614950007612
Quantity per Package
25
Contains DI Package
00614950007615
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvec Bag
| 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 |