Duns Number:275273795
Device Description: Single-use, sterile resorbable bone substitute
Catalog Number
01S0500
Brand Name
R.T.R. Syringe
Version/Model Number
01S0500
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
3c3c0d01-dc2b-4a37-9250-66af3568986b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 20, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |
| U | Unclassified | 1 |