AccessGUDID - DEVICE: Eon Mini™ (05414734402613)

GUDID

Device Identifier (DI) Information

Brand Name: Eon Mini™
Version or Model: 3719
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3719
Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.

Primary DI Number: 05414734402613
Issuing Agency: GS1
Commercial Distribution End Date: March 28, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 021675699 *Terms of Use

Device Description: Charging System Charger

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):	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
External device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to an external parent device (i.e., nonimplantable device) or external battery pack, to recharge it for operation.

FDA Product Code

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Product Code	Product Code Name
LGW	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Storage Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eb2770fc-5a62-4716-8a81-890ed579626b
Public Version Date: April 23, 2018
Public Version Number: 4
DI Record Publish Date: October 22, 2014