- Physicians Office Resource

NEEDLE 041829 5 INCH GLOBAL FLEX
INTERSTIM® - 041829

Device Description

A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

57.00
-34.00

Storage Environment Temperature - Degrees Fahrenheit

135.00
-30.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: EZW

Device Name: Stimulator, Electrical, Implantable, For Incontinence

Device Class: 3

Physical State: N/A

Definition: PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))

Submission Type ID: 2

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 876.5270

Third Party Flag: N

Medical Specialty: GU

Code: QON

Device Name: Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

Device Class: 3

Physical State: Receiver implanted in the abdomen with electrodes for pulsed-stimulation that are implanted either in the bladder wall or in the pelvic floor, and a battery-powered transmitter outside the body

Definition: Treatment of chronic fecal incontinence

Submission Type ID: 2

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Electrical stimulation of the sacral nerve

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Sacral nerve, bladder, urinary and anal sphincters, pelvic floor, and rectosigmoid colon

Regulation Number: 876.5270

Third Party Flag: N

Medical Specialty: GU

Device Identifiers

Device Id: 20643169721153

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 00643169721159

Device Type: Unit of Use

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.