Duns Number:483599259
Device Description: BLX Implant, Ø 6.5mm WB, SLA® 16mm, Roxolid®
Catalog Number
061.9516
Brand Name
BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
Version/Model Number
SLA Roxolid BL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K212533
Product Code
DZE
Product Code Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Public Device Record Key
8ca5928c-6185-4b78-8c42-a8ff903f86cd
Public Version Date
March 09, 2022
Public Version Number
1
DI Record Publish Date
March 01, 2022
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 | 52 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2726 |
| 3 | A medical device with high risk that requires premarket approval | 5 |