Duns Number:083171244
Device Description: creos™ xenocote Absorbable Collagen Wound Dressing for Dental Surgery
Catalog Number
WD62201
Brand Name
creos™
Version/Model Number
WD62201
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
LPG
Product Code Name
MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Public Device Record Key
0be49e0a-2a74-4394-9a70-310671034b7d
Public Version Date
October 25, 2022
Public Version Number
4
DI Record Publish Date
September 28, 2018
Package DI Number
30381780490023
Quantity per Package
4
Contains DI Package
10381780490029
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |