Efficient Care 3D Planning 302.4014

GUDID 00887868397547

Orthosoft Inc

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software

• Primary Device ID: 00887868397547
• NIH Device Record Key: b647c073-a793-4fd0-809d-85b831cb215f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Efficient Care 3D Planning
• Version Model Number: 302.4014
• Catalog Number: 302.4014
• Company DUNS: 205670032
• Company Name: Orthosoft 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: true
• 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: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868397547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183544

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-25
• Device Publish Date: 2019-10-17

Devices Manufactured by Orthosoft Inc

• 00887868557873 - ROSA® Shoulder: 2024-03-14
• 00887868557880 - ROSA® Shoulder: 2024-03-14
• 00887868557897 - ROSA® Shoulder: 2024-03-14
• 00887868557903 - ROSA® Shoulder: 2024-03-14
• 00887868557910 - ROSA® Shoulder: 2024-03-14
• 00887868558078 - ROSA® Shoulder: 2024-03-14
• 00887868558092 - ROSA® Shoulder: 2024-03-14
• 00887868558108 - ROSA® Shoulder: 2024-03-14