- Physicians Office Resource

ACC 3065USC PNE KIT ETO US BOWEL
INTERSTIM - 3065USC

Device Description

A sterile wire, insulated with non-conductive material except at its electrode(s), intended to be percutaneously introduced short-term (<=30 days) to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence, by making to make an electrical connection between an external electrical stimulation system pulse generator and the sacral plexus. 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

Device Identifiers

Device Id: 00613994572011

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

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