AutoPlex, VertaPlex

Basic Information

• Brand Name: AutoPlex, VertaPlex
• Primary DI: 07613154687152
• Version / Model: 0605685000
• Catalog Number: 0605-685-000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-29
• Public Version: 8
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: df66e843-a7be-43cd-aea1-2086229b6ed2
• Distribution End Date: 2021-07-08

Device Description

System with Needle and Bone Cement

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDZ	MIXER, CEMENT, FOR CLINICAL USE	Orthopedic	888.4210	1
LOD	BONE CEMENT	Orthopedic	888.3027	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47742	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37613154687153	GS1	pack	2	Not in Commercial Distribution	2021-07-08
Primary	07613154687152	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	5.0	Inch
Needle Gauge	13.0	Gauge

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius