OPERON

Basic Information

• Brand Name: OPERON
• Primary DI: 07613327395136
• Version / Model: OZ 7568875
• Catalog Number: OZ 7568875
• Company Name: STRYKER COMMUNICATIONS INC.
• Labeler DUNS: 078807493
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-24
• Public Version: 4
• Public Version Date: 2021-04-29
• Public Version Status: Update
• Public Device Record Key: 5a5f96f0-776e-438d-a973-af8c453842ff
• Distribution End Date: 2021-04-29

Device Description

Surgical Table Pad, 3 Inch Rotational Vascular Arm

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
LWG	SURGICAL TABLE CUSHION	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35184	Operating table mattress, basic	A foam-filled cushion designed as a component of an operating table to serve as the surface upon which the patient is placed. It is typically filled with high-density polyurethane or a memory foam, and may be an integral part of the table (i.e., removable only with tools) or loosely fitted to the table top (e.g., by way of press studs, Velcro strips, or eyeholes and pegs) and is removable for cleaning. The device is firm, waterproof, and washable using strong disinfectants. It is available as one full-length piece or in sections. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327395136	GS1

Customer Contacts

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