AccessGUDID - DEVICE: AutoPlex, VertaPlex (07613154687152)

GUDID

Device Identifier (DI) Information

Brand Name: AutoPlex, VertaPlex
Version or Model: 0605685000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0605-685-000
Company Name: STRYKER CORPORATION

Primary DI Number: 07613154687152
Issuing Agency: GS1
Commercial Distribution End Date: July 08, 2021
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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JDZ	MIXER, CEMENT, FOR CLINICAL USE
LOD	BONE 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

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Length: 5.0 Inch
Needle Gauge: 13.0 Gauge

Device Record Status

Public Device Record Key: df66e843-a7be-43cd-aea1-2086229b6ed2
Public Version Date: November 18, 2021
Public Version Number: 8
DI Record Publish Date: December 29, 2016