Duns Number:081315444
Device Description: Acetabular Shell Screw, 6.5mm Cancellous Bone Screw; Ti alloy; 55mm Length
Catalog Number
8814006555
Brand Name
b-ONE™ Primary Acetabular System
Version/Model Number
8814006555
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
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
1844fc26-f22f-49d0-aead-7b67d87c0397
Public Version Date
March 18, 2019
Public Version Number
1
DI Record Publish Date
March 08, 2019
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 | 273 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 707 |