Duns Number:083171244
Device Description: Trel-XPress 300c, 2.5cc is made using demineralized human bone and cancellous chips mixed Trel-XPress 300c, 2.5cc is made using demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300c is formulated into a putty form and is provided in a sterile, single use package.
Catalog Number
XPres3c25
Brand Name
Trel XPress 300C
Version/Model Number
XPres3c25
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"
Yes
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
K091193
Product Code
MBP
Product Code Name
Filler, bone void, osteoinduction (w/o human growth factor)
Public Device Record Key
aa3a6f6d-b4f6-4960-ab7c-a245560c133c
Public Version Date
October 02, 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 |