Duns Number:196548481
Device Description: Precision System with Extension Tube/ Radiopaque Bone Cement
Catalog Number
0505-587-000
Brand Name
PCD
Version/Model Number
0505587000
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
LOD
Product Code Name
BONE CEMENT
Public Device Record Key
e62d7e85-2f2f-4500-9ecd-f3dc8b4bd371
Public Version Date
November 02, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
34546540434419
Quantity per Package
4
Contains DI Package
04546540434418
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |