AccessGUDID - DEVICE: SJM™ (05414734400138)

GUDID

Device Identifier (DI) Information

Brand Name: SJM™
Version or Model: 1115
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1115
Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.

Primary DI Number: 05414734400138
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: Epidural Needle, 15 gauge, 4" (10cm)

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
Epidural needle, non-threaded	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device.

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

Clinically Relevant Size

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Size Type Text
Needle Gauge: 15 Gauge

Device Record Status

Public Device Record Key: 69570536-6023-4229-b703-ab6911a5c126
Public Version Date: April 30, 2018
Public Version Number: 4
DI Record Publish Date: October 23, 2014