Duns Number:053950783
Device Description: AttraX Scaffold Morsels, 10cc
Catalog Number
-
Brand Name
AttraX
Version/Model Number
5015110
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
K172497
Product Code
MQV
Product Code Name
FILLER, BONE VOID, CALCIUM COMPOUND
Public Device Record Key
eb7fc9e5-39c1-4e1b-adc9-1a677df619ad
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
June 05, 2018
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 | 4207 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38751 |
| 3 | A medical device with high risk that requires premarket approval | 84 |
| U | Unclassified | 29 |