OPERON

Basic Information

• Brand Name: OPERON
• Primary DI: 07613327354294
• Version / Model: OZ 7527675
• Catalog Number: OZ 7527675
• Company Name: STRYKER COMMUNICATIONS INC.
• Labeler DUNS: 078807493
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-24
• Public Version: 1
• Public Version Date: 2019-02-25
• Public Version Status: New
• Public Device Record Key: 90a83a1d-4947-491b-aad8-5f320b1160a7

Device Description

Surgical Table,INSIDE RAIL CLAMP

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
GDC	TABLE, OPERATING-ROOM, ELECTRICAL	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37050	Medical table clamp	A device that is designed to be used together with operating tables and certain kinds of examination/treatment tables. It can have different fixation/locking mechanisms, but is often designed to fit onto the side rails of such tables. It is used to hold different components and accessories onto the table providing added functionality. Such devices can be footrests, transducer holders, anaesthesia screen holders. The clamp allows for easy and safe adjustments of the position of these accessory devices and provides a secure locking mechanism. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327354294	GS1

Customer Contacts

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