NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207045015
• Version / Model: 8982025
• Catalog Number: 8982.025
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-28
• Public Version: 5
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 040d1923-f196-4ba8-a750-a24a2cba3a12
• Distribution End Date: 2018-11-30

Device Description

VAGINOSCOPE-TUBE ID 7.5MM OD 9.5MM for adults, TL 107mm, distal end straight, reusable

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Ethylene Oxide", "Hydrogen Peroxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOK	VAGINOSCOPE AND ACCESSORIES	Obstetrics/Gynecology	884.1630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15630	Vaginoscope	A hand-held endoscope intended to be used for the examination of the vagina, usually in children, typically when searching for foreign bodies or sources of bleeding. It typically includes an optical vaginal speculum and magnification device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207045015	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	7.5	Millimeter
Outer Diameter	9.5	Millimeter