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 IdentifiersDevice 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