Wallace

Basic Information

• Brand Name: Wallace
• Primary DI: 15019315015366
• Version / Model: 700/300/100
• Company Name: Smiths Medical International Ltd
• Labeler DUNS: 215591523
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-05
• Public Version: 4
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: 785245a9-e8db-43de-ba74-2ee86ae4c2ce
• Distribution End Date: 2019-09-27

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHW	PESSARY, VAGINAL	Obstetrics/Gynecology	884.3575	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34149	Pelvic-organ-supporting pessary	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	35019315015360	GS1	Box	10	Not in Commercial Distribution	2019-09-27
Primary	15019315015366	GS1
Package	55019315015364	GS1	Carton	100	Not in Commercial Distribution	2019-09-27