Accu Spina / Spina System Cervical

GUDID 00869444000218

Physiotherapeutic treament device

NORTH AMERICAN MEDICAL CORPORATION

Static/intermittent powered traction system, non-mobile

• Primary Device ID: 00869444000218
• NIH Device Record Key: df6ba08c-8bf6-4e9d-91fc-594ae3d9a749
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu Spina / Spina System Cervical
• Version Model Number: 21
• Company DUNS: 031023091
• Company Name: NORTH AMERICAN MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 770-541-0012
• Email: office@namcorporation.com

Device Dimensions

• Height: 88 Inch
• Height: 88 Inch
• Height: 88 Inch

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869444000218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033231

FDA Product Code

• ITH: Equipment, Traction, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24