NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207040027
• Version / Model: 837891
• Catalog Number: 8378.91
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-27
• Public Version: 2
• Public Version Date: 2023-01-20
• Public Version Status: Update
• Public Device Record Key: f7702cb7-afee-4824-bce8-e065854fbcbd

Device Description

PORTIO CONE ATTACHMENT SZ LARGE for introduction of fluid for hysterosalpingography, curved upwards, compatible with intrauterine probe 8378001, with Luer connection, 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: No
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHI	System, abortion, vacuum	Obstetrics/Gynecology	884.5070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63993	Uterine probe	A slender, rod-like, hand-held manual surgical instrument intended to be used to explore the uterus during a surgical procedure. It is typically intended to be used as a component of a uterine manipulator and as such may have a suction channel for applying a vacuum to fixate the manipulator assembly to the uterus. It is made of metal with an atraumatic tip; it may include graduated markings. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207040027	GS1

Customer Contacts

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