Voss Cervical Laminectomy Harness

Basic Information

• Brand Name: Voss Cervical Laminectomy Harness
• Primary DI: 00811304020140
• Version / Model: CLH-58K
• Company Name: VM/POSITIONING, INC.
• Labeler DUNS: 023574260
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-31
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 2dc25aac-59c2-4841-995c-17d9aa004c9a

Device Description

Voss CLH Kit is is used for shoulder retraction.

Device Characteristics

• Single Use: Yes
• 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: 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
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45259	Head/neck immobilizer, single-use	A rigid or non-rigid, non-sterile, device usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811304020140	GS1