DEVICE: PCD SpinePlex (04546540434371)
Device Identifier (DI) Information
PCD SpinePlex
0505582000
Not in Commercial Distribution
0505-582-000
STRYKER CORPORATION
0505582000
Not in Commercial Distribution
0505-582-000
STRYKER CORPORATION
Precision System with Needle/Radiopaque Bone Cement
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
33191 | Manual orthopaedic cement mixer, reusable |
A hand-operated manual device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically includes a single-use inner mixing bowl where the cement is mixed, an outer housing with a handcrank and driving gears connected to a disposable mixing blade(s), and a lid. The device is intended to be connected to, or placed under, a fume extraction device to prevent fumes from polluting the working environment; it is typically operated outside of the sterile surgical field. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LOD | BONE CEMENT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 0 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Needle Gauge: 10.0 Gauge |
Device Record Status
32815722-b318-4713-9001-5172a2b9ada9
November 18, 2021
7
September 24, 2015
November 18, 2021
7
September 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
34546540434372 | 4 | 04546540434371 | 2021-07-08 | Not in Commercial Distribution | pack |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)253-3210
Inst.Stryker.cs@Stryker.com
Inst.Stryker.cs@Stryker.com