DEVICE: AutoPlex, VertaPlex (07613154687152)

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Device Identifier (DI) Information

AutoPlex, VertaPlex
0605685000
0605685000
STRYKER CORPORATION
07613154687152
GS1
1
System with Needle and 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
Orthopaedic cement mixing container, single-use A sterile device in which an orthopaedic cement dispenser is intended to be placed to maintain the sterility of the dispenser and its contents (orthopaedic cement) when it is taken out of the sterile field to be mixed by an automatic mixer during a surgical procedure. It is typically made of plastic material and designed to be passed by operating staff from the sterile field to staff who may not be sterile, and back again, without compromising the sterility of its contents. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
JDZ MIXER, CEMENT, FOR CLINICAL USE
NDN CEMENT, BONE, VERTEBROPLASTY
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
Handling Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between -20 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 5.0 Inch
Needle Gauge: 13.0 Gauge
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Device Status

In Commercial Distribution
December 29, 2016

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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
37613154687153 2 07613154687152 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

[?]
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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