Duns Number:042763706
Device Description: RCF COLLAGEN FOAM 3MM THICK 2CM X 4CM RESORBABLE 10/BOX
Catalog Number
5092000
Brand Name
RCF Resorbable Collagen Foam
Version/Model Number
5092000
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
b3c56323-3f6d-47c8-81b7-7303aa498fbb
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
October 24, 2015
Package DI Number
10614950007223
Quantity per Package
10
Contains DI Package
00614950007226
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 |