Duns Number:079118736
Device Description: GLADIATOR® BIPOLAR 61MM OD X 36MM ID
Catalog Number
GLBP3661
Brand Name
GLADIATOR® BIPOLAR
Version/Model Number
GLBP3661
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
KWY
Product Code Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Public Device Record Key
ca5d41a4-c4b6-4e3f-9536-fd81580df3f3
Public Version Date
September 09, 2020
Public Version Number
3
DI Record Publish Date
October 20, 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 | 7823 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12222 |
| 3 | A medical device with high risk that requires premarket approval | 109 |