Duns Number:083171244
Device Description: SALVIN OraCOTE® Absorbable Collagen Wound Dressing for Dental Surgery, 3/4in x 1 1/2in
Catalog Number
#ORACOTE-PKG-10
Brand Name
ORACOTE®
Version/Model Number
#ORACOTE-PKG-10
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
f0393dc7-8f04-4c72-8b5a-1b3507885be2
Public Version Date
April 19, 2021
Public Version Number
8
DI Record Publish Date
September 11, 2014
Package DI Number
30381780000314
Quantity per Package
4
Contains DI Package
10381780000310
Package Discontinue Date
March 31, 2020
Package Status
Not 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 |