Signature ONE Software Package 302.4018

GUDID 00889024647039

v. 1.1

Orthosoft Inc

Radiology DICOM image processing application software

• Primary Device ID: 00889024647039
• NIH Device Record Key: c6c7053e-4b62-4236-a9bd-571854f88be2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signature ONE Software Package
• Version Model Number: 302.4018
• Catalog Number: 302.4018
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024647039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190595

FDA Product Code

• QHE: Shoulder Arthroplasty Implantation System

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: 2022-07-13
• Device Publish Date: 2022-07-05

On-Brand Devices [Signature ONE Software Package]

• 00889024647046: v. 1.2
• 00889024647039: v. 1.1
• 00889024585393: v. 1.0