Cervical Spine Frame

Basic Information

• Brand Name: Cervical Spine Frame
• Primary DI: 04946329317886
• Version / Model: 08-007-22-R2
• Catalog Number: 08-007-22-R2
• Company Name: MIZUHO CORPORATION
• Labeler DUNS: 690677802
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-02
• Public Version: 1
• Public Version Date: 2021-07-12
• Public Version Status: New
• Public Device Record Key: 113d74ac-c21e-4db8-bc33-78ea5817d1a4

Device Description

Cervical Spine Frame (R2)

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: Yes
• 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
46208	Spinal surgery positioning board	A device comprised of a supportive foundation and adjustable positioning elements designed to be attached to an operating table to enable correct positioning and immobilization of a patient during surgical procedures involving the spine (e.g., thoracolumbrosacral surgery, disc decompression). It supports the patient in the prone or supine position providing a close approximation to a patient's natural lumbar lordosis while facilitating reduced abdominal compression. It typically consists of a base plate/board made of durable materials (e.g., metal, carbon fibre) to which other devices are attached (e.g., intraoperative positioners, headrest, x-ray cassette). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04946329317886	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	1200	Millimeter