Duns Number:083171244
Device Description: Trel-X™Gel, 1cc is human bone that has been demineralized and combined with poloxamer rev Trel-X™Gel, 1cc is human bone that has been demineralized and combined with poloxamer reverse phase medium which is formulated into a gel or putty-like form. Trel-X is provided in a sterile, single patient use package.
Catalog Number
TXG01
Brand Name
Trel-X Gel
Version/Model Number
TXG01
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)
Yes
FDA Premarket Submission
K040419
Product Code
MQV
Product Code Name
FILLER, BONE VOID, CALCIUM COMPOUND
Public Device Record Key
c7ce8dd0-ff63-44f9-8baa-7e5fa1cd17b6
Public Version Date
September 22, 2020
Public Version Number
5
DI Record Publish Date
September 22, 2015
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 | 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 |