Product Overview

Wallace - 700/300/095


Device Description

A device made of rubber or soft plastics designed for insertion into the vagina to hold the uterus, bladder and/or rectum in place and help prevent prolapse (falling or sliding of the organ from its normal position into the pelvic cavity), either as a permanent or temporary treatment; it is not dedicated to bladder-only support. It is available in a variety of shapes (e.g., rings, stems) and sizes; it may be fitted for each woman individually. This is a reusable device after appropriate cleaning.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: HHW

Device Name: Pessary, Vaginal

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 884.3575

Third Party Flag: Y

Medical Specialty: OB


Device Identifiers

Device Id: 55019315015357

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 35019315015353

Package Quantity: 100

Package Discontinue Date: 9/27/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Carton


Device Id: 35019315015353

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15019315015359

Package Quantity: 10

Package Discontinue Date: 9/27/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Box


Device Id: 15019315015359

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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