AccessGUDID - DEVICE: SJM™ (05414734400794)

GUDID

Device Identifier (DI) Information

Brand Name: SJM™
Version or Model: Communication Wand
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1232
Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.

Primary DI Number: 05414734400794
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021675699 *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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

GMDN Preferred Term Name	GMDN Definition
Active-implantable-device communicator	A non-sterile electronic device, typically hand-held, intended to be used to communicate (e.g., via radio-frequency) with an active implantable device (e.g., a pulse generator) to receive information on device and/or physiologic performance, and/or to select and actuate one or more of the programmed operating parameters of the implanted device. This device may be operated by a physician or patient.

GMDN Preferred Term Name

GMDN Definition

Active-implantable-device communicator

A non-sterile electronic device, typically hand-held, intended to be used to communicate (e.g., via radio-frequency) with an active implantable device (e.g., a pulse generator) to receive information on device and/or physiologic performance, and/or to select and actuate one or more of the programmed operating parameters of the implanted device. This device may be operated by a physician or patient.

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

[?]

Storage and Handling
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
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8d0dc37e-de13-48b2-9833-664f2f4d3e00
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 21, 2014