NA

Basic Information

• Brand Name: NA
• Primary DI: 07613327170467
• Version / Model: OZ 1705604
• Catalog Number: OZ 1705604
• Company Name: Berchtold Holding GmbH
• Labeler DUNS: 316153824
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-25
• Public Version: 1
• Public Version Date: 2021-06-02
• Public Version Status: New
• Public Device Record Key: d610e60d-b9ae-4bd5-aadc-29fba4ac5086

Device Description

TUR position module, Operon D 750-D 850, EU. Keep Dry.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
CCX	SUPPORT, PATIENT POSITION	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37256	Urological operating table top	A component of a modular operating table designed as a detachable table top to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. Its surface consists of a flat section that may have motor-driven longitudinal traverse, a headrest, adjustable leg holders and facilitate a urine/irrigation fluid collection tray with a filter to catch urinary stones/fragments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327170467	GS1