Tenzor Radiolucent Carbon Fiber Spine Positioning Frame

Basic Information

• Brand Name: Tenzor Radiolucent Carbon Fiber Spine Positioning Frame
• Primary DI: 00810105030297
• Version / Model: 4-0009-001
• Company Name: COMPOSITE MANUFACTURING, INC.
• Labeler DUNS: 947090650
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-14
• Public Version: 1
• Public Version Date: 2020-02-24
• Public Version Status: New
• Public Device Record Key: bd6c9ad7-3c3e-4fb5-8a2e-1878919db0f6

Device Description

Radiolucent Spine positioning traction frame. Arcing flexures are used to arc the patients spine while in the prone position to expose the spine for surgical procedures.

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: Yes
• Has Serial Number: Yes
• 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
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46762	Traction table, manual	A mobile, manually-operated, table designed to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a mechanical altering of the table surface geometry. The surface typically consists of sections that can be raised and lowered to manipulate the curvature of the patient?s spine whilst he/she lies in a supine position. Interchangeable traction devices such as head halters, pelvic belts, traction boots, and a traction unit may be used with this table. It is typically used in a healthcare facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810105030297	GS1

Customer Contacts

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