Duns Number:081315444
Device Description: Cementless Acetabular Shell, Cluster Hole; Porous Plasma Spray + HA Coating; 54mm Outer Cementless Acetabular Shell, Cluster Hole; Porous Plasma Spray + HA Coating; 54mm Outer Diameter, Liner Size H
Catalog Number
881311541H
Brand Name
b-ONE™ Primary Acetabular System
Version/Model Number
881311541H
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
b5984101-1cb0-4df5-a105-890ab7a415ff
Public Version Date
March 19, 2019
Public Version Number
1
DI Record Publish Date
March 11, 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 |