Spectre

GUDID B308SPECT0

Wireless Foot switch / Hand switch system for use with OEC 9800/9900 Mobile C-Arms.

CANYON RIDGE RESOURCES LIMITED LIABILITY COMPANY

Foot-switch, electrical Foot-switch, electrical

• Primary Device ID: B308SPECT0
• NIH Device Record Key: feed2351-372b-44e1-9820-6fa7393171cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectre
• Version Model Number: 98/9900
• Company DUNS: 829002815
• Company Name: CANYON RIDGE RESOURCES LIMITED LIABILITY COMPANY
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B308SPECT0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092713

FDA Product Code

• IZL: System, X-Ray, Mobile

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-12