AccessGUDID - DEVICE: Power-PRO 2, High Configuration (07613327559118)

GUDID

Device Identifier (DI) Information

Brand Name: Power-PRO 2, High Configuration
Version or Model: 650705550001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 650705550001
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327559118
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078470558 *Terms of Use

Device Description: No description.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
60487	Ambulance stretcher, electrohydraulic	A battery-powered device consisting of a platform mounted on a wheeled frame, intended for use by emergency medical services (EMS) primarily to facilitate easy transport of a recumbent patient to and from ambulance vehicles (e.g., automobiles, aircraft, boats), whilst allowing the operator to raise and lower the platform using powered switches. It has an electrically-powered hydraulic undercarriage (e.g., X-frame) which can raise/lower the patient and is collapsible for ambulance loading; ambulance-mounted locking/docking devices may be included. The patient platform is typically hydraulically adjustable.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPO	STRETCHER, WHEELED

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -30 and 130 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between -30 and 130 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f36bd152-3e42-43a9-bffe-8c257a68c753
Public Version Date: November 22, 2022
Public Version Number: 2
DI Record Publish Date: September 20, 2021