Wallach

Basic Information

• Brand Name: Wallach
• Primary DI: 00888937017045
• Version / Model: 920008
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-10
• Public Version: 3
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: 22d5ade9-8eb1-4801-ae33-3049fe9b21e3

Device Description

FLEXISOUND Intrauterine Sound

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13644	Uterine sound, reusable	A hand-held manual instrument designed to measure and/or explore the internal depth or length of the uterus, cervix, and/or vagina. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20888937017049	GS1	2	25	In Commercial Distribution
Primary	00888937017045	GS1