N/A ECO-ER-CAT-001Pro

GUDID 08800019200437

-Extraoral source x-ray system Battery Input: 22.2V, 1A Output Rating: 210W kVp: 70kV mA:3mA Sec: 0.02 - 0.5sec

ECOTRON

Hand-held intraoral dental x-ray system, digital

• Primary Device ID: 08800019200437
• NIH Device Record Key: 2ccac57d-5614-4dbf-b307-78e1fec08066
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: ProX Go
• Catalog Number: ECO-ER-CAT-001Pro
• Company DUNS: 688209954
• Company Name: ECOTRON
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9999999999
• Email: export@ecotron.co.kr
• Phone: 9999999999
• Email: export@ecotron.co.kr
• Phone: 9999999999
• Email: export@ecotron.co.kr
• Phone: 9999999999
• Email: export@ecotron.co.kr
• Phone: 9999999999
• Email: export@ecotron.co.kr
• Phone: 9999999999
• Email: export@ecotron.co.kr
• Phone: 9999999999
• Email: export@ecotron.co.kr
• Phone: 9999999999
• Email: export@ecotron.co.kr
• Phone: 9999999999
• Email: export@ecotron.co.kr
• Phone: 9999999999
• Email: export@ecotron.co.kr
• Phone: 9999999999
• Email: export@ecotron.co.kr
• Phone: 9999999999
• Email: export@ecotron.co.kr
• Phone: 9999999999
• Email: export@ecotron.co.kr
• Phone: 9999999999
• Email: export@ecotron.co.kr

Device Dimensions

• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram
• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram
• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram
• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram
• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram
• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram
• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram
• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram
• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram
• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram
• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram
• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram
• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram
• Width: 165 Millimeter
• Length: 259 Millimeter
• Height: 277 Millimeter
• Weight: 1.86 Kilogram

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800019200437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221233

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2025-03-24
• Device Publish Date: 2025-03-14

On-Brand Devices [N/A]

• 08800019200406: - Extraoral source x-ray system Battery Input: 22.2V, 1A Output Rating: 210W kVp: 70kV mA: 3mA S
• 08800019200437: -Extraoral source x-ray system Battery Input: 22.2V, 1A Output Rating: 210W kVp: 70kV mA:3mA Sec