- Physicians Office Resource

DISPOSABLE CANNULA - PR-19A

Device Description

A flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, syringe). 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: NWW

Device Name: Hysteroscope Accessories

Device Class: 1

Physical State: Metal instruments

Definition: Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Submission Type ID: 4

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Part of system that advances through the working channel of the hysteroscope to perform it's function.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Uterus

Regulation Number: 884.1690

Third Party Flag: N

Medical Specialty: OB

Device Identifiers

Device Id: 14953170049429

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170049422

Package Quantity: 6

Package Discontinue Date: 8/15/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A

Device Id: 04953170049422

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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