D-EVO Suite FSx

GUDID 00858340006400

The FM-OTC18T is the version of the D-EVO Suite FSx system which uses an overhead tube crane and performs synchronized tracking. This x-ray system can perform a comprehensive range of radiographic procedures.

Del Medical, Inc.

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• Primary Device ID: 00858340006400
• NIH Device Record Key: e744faf7-e585-4e12-ab0d-3a0f4c41f75c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-EVO Suite FSx
• Version Model Number: FM-OTC18T
• Company DUNS: 078671236
• Company Name: Del Medical, 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	00858340006400 [Primary]

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2024-03-26
• Device Publish Date: 2024-03-18

On-Brand Devices [D-EVO Suite FSx]

• 00858340006431: The FM-FMT18M is the version of the D-EVO Suite FSx system which uses a floor mounted tube stand
• 00858340006424: The FM-FMT18T is the version of the D-EVO Suite FSx system which uses a floor mounted tube stand
• 00858340006417: The FM-OTC18M is the version of the D-EVO Suite FSx system which uses an overhead tube crane and
• 00858340006400: The FM-OTC18T is the version of the D-EVO Suite FSx system which uses an overhead tube crane and