AccessGUDID - DEVICE: AutoPlex, VertaPlex (07613154687145)

GUDID

Device Identifier (DI) Information

Brand Name: AutoPlex, VertaPlex
Version or Model: 0605683000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0605683000
Company Name: STRYKER CORPORATION

Primary DI Number: 07613154687145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: System with Needle and Bone Cement

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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

GMDN Preferred Term Name	GMDN Definition
Orthopaedic cement preparation/delivery kit	A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
OAR	Injector, vertebroplasty (does not contain cement)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 25 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Length: 5.0 Inch
Needle Gauge: 11.0 Gauge

Device Record Status

Public Device Record Key: 3b99174b-6f97-4995-aece-978b60f96810
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016