- Physicians Office Resource

Dornier Magellan Ureteral Access Sheath, 12/14Fr x 45cm
Dornier MedTech - Dornier Magellan Ureteral Access Sheath, 12/14Fr x 45cm

Device Description

A flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: FED

Device Name: Endoscopic Access Overtube, Gastroenterology-Urology

Device Class: 2

Physical State: overtube

Definition: To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Endoscope inserted and advanced through center of device

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various openings in gi and gu tract

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Identifiers

Device Id: 00810116021635

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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