SPY-PHI System

GUDID 00810007560007

SPY-PHI Articulating Arm, Main Arm

AXCESS SURGICAL INNOVATIONS, LLC

Surgical instrument assist arm system, manually-adjusted

• Primary Device ID: 00810007560007
• NIH Device Record Key: 490072da-c97f-45de-b550-b535ef3e5efc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPY-PHI System
• Version Model Number: HH1001
• Company DUNS: 968677414
• Company Name: AXCESS SURGICAL INNOVATIONS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810007560007 [Primary]

FDA Product Code

• FWZ: Operating Room Accessories Table Tray

Sterilization

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

[00810007560007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-06
• Device Publish Date: 2019-08-29

On-Brand Devices [SPY-PHI System]

• 00810007560021: SPY-PHI Articulating Arm, Imaging Head Holder
• 00810007560014: SPY-PHI Articulating Arm, Table Clamp
• 00810007560007: SPY-PHI Articulating Arm, Main Arm