VMA DataLink Software

GUDID 00868579000216

ORTHO KINEMATICS, INC.

Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software

• Primary Device ID: 00868579000216
• NIH Device Record Key: 3039857c-de00-4944-aa5a-833d87e381d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VMA DataLink Software
• Version Model Number: 2.3
• Company DUNS: 932053221
• Company Name: ORTHO KINEMATICS, INC.
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com
• Phone: 512-334-5490
• Email: info@orthokinematics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868579000216 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-23
• Device Publish Date: 2016-09-22

On-Brand Devices [VMA DataLink Software]

• 00868579000223: VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site
• 00868579000216: 2.3