Panther OIS

GUDID 00859032007156

PROWESS, INC.

Radiation therapy treatment record/verify system

• Primary Device ID: 00859032007156
• NIH Device Record Key: 0c229143-4286-4d44-9d4c-c5a7c2ab2158
• Commercial Distribution Discontinuation: 2027-03-16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panther OIS
• Version Model Number: v3.0
• Company DUNS: 002162728
• Company Name: PROWESS, 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	00859032007156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211760

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2022-03-24
• Device Publish Date: 2022-03-16

On-Brand Devices [Panther OIS]

• 00859032007156: v3.0
• 00859032007309: Panther OIS 3.2
• 00859032007262: Panther OIS 3.12
• 00859032007248: Panther OIS 3.11
• 00859032007224: Panther OIS 3.1