NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207014882
• Version / Model: 8370511
• Catalog Number: 8370.511
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 6
• Public Version Date: 2023-05-26
• Public Version Status: Update
• Public Device Record Key: 279d184b-16dc-428e-b77a-016285d87ff4
• Distribution End Date: 2018-11-30

Device Description

UTERUS PROBE SZ SHORT Ø 7.5MM WL 37MM curved upwards, compatible with uterus manipulator 8370501, 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: No
• 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", "Hydrogen Peroxide", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HEW	Culdoscope (and accessories)	Obstetrics/Gynecology	884.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58051	Uterine manipulator, single-use	A sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207014882	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	37	Millimeter
Outer Diameter	7.5	Millimeter