Duns Number:042763706
Device Description: *SPECIAL ORDER* RCT COLLAGEN TAPE 7.5X2.5CMX1MM Thick 10/BAG
Catalog Number
5091000
Brand Name
RCT Resorbable Collagen Tape
Version/Model Number
T5091000
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
27cf3546-617b-418d-a846-8e024b49550f
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
January 18, 2016
Package DI Number
10614950008145
Quantity per Package
10
Contains DI Package
00614950008148
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 |