Duns Number:109903521
Device Description: TANDEM INTERNATIONAL BIPOLAR 38MM OUTER DIAMETER 22MM I TANDEM INTERNATIONAL BIPOLAR 38MM OUTER DIAMETER 22MM INNER DIAMETER
Catalog Number
71324038
Brand Name
TANDEM
Version/Model Number
71324038
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
K023743
Product Code
KWY
Product Code Name
Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Public Device Record Key
68e21b52-865d-431d-ae9b-f4d8a76db4fd
Public Version Date
October 11, 2021
Public Version Number
6
DI Record Publish Date
August 30, 2015
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |