DEVICE: PCD SpinePlex (04546540434395)

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Device Identifier (DI) Information

PCD SpinePlex
0505585000
0505585000
STRYKER CORPORATION
04546540434395
GS1
1
Precision System with Needle/ Radiopaque Bone Cement
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
LOD BONE CEMENT
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 13.0 Gauge
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Device Status

In Commercial Distribution
September 24, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
34546540434396 4 04546540434395 In Commercial Distribution pack
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)253-3210
Inst.Stryker.cs@Stryker.com
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