Prodigy

GUDID 00840682117142

GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

Bone absorptiometric x-ray system, dual-energy

• Primary Device ID: 00840682117142
• NIH Device Record Key: 9a826890-7a56-4410-9b97-5f9475d27a2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodigy
• Version Model Number: C1
• Company DUNS: 078863378
• Company Name: GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682117142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133664

FDA Product Code

• KGI: Densitometer, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-06
• Device Publish Date: 2016-06-27

On-Brand Devices [Prodigy]

• 00840682138352: C2
• 00840682138345: F2
• 00840682117142: C1
• 00840682117098: F1