Duns Number:085976260
Device Description: Bipolar Assembly, 22mm×43mm, +6mm
Catalog Number
1020-0-4243
Brand Name
Consensus Hip System
Version/Model Number
1020-0-4243
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KWY
Product Code Name
Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Public Device Record Key
ffd84d87-76cc-4918-a725-3c6e2a9e10aa
Public Version Date
January 24, 2022
Public Version Number
1
DI Record Publish Date
January 15, 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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3570 |
| 3 | A medical device with high risk that requires premarket approval | 108 |