WALLACH

Basic Information

• Brand Name: WALLACH
• Primary DI: 50888937010171
• Version / Model: 920010
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 6
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: e4b501c2-03a4-4f02-9b45-be03e922e7d7
• Distribution End Date: 2023-10-02

Device Description

WALLACH® Disposable Vaginal Speculum Medium

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37468	Vaginal speculum, single-use	A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	50888937010171	GS1
Package	20888937010170	GS1		10	Not in Commercial Distribution	2023-10-02
Package	40888937010174	GS1		48	Not in Commercial Distribution	2023-10-02

Premarket Submissions

Submission Number	Supplement Number
K841909	000