OptoWire F1012

GUDID 07540184110124

Pressure guidewire

Opsens Inc

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• Primary Device ID: 07540184110124
• NIH Device Record Key: f34ff046-c57c-4b3b-b9b8-edc6d3dae0d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptoWire
• Version Model Number: Deux
• Catalog Number: F1012
• Company DUNS: 253717946
• Company Name: Opsens 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 175 Centimeter
• Length: 175 Centimeter
• Length: 175 Centimeter
• Length: 175 Centimeter
• Length: 175 Centimeter
• Length: 175 Centimeter
• Length: 175 Centimeter
• Length: 175 Centimeter
• Length: 175 Centimeter
• Length: 175 Centimeter
• Length: 175 Centimeter
• Length: 175 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540184110124 [Primary]
GS1	07540184310128 [Package]; Contains: 07540184510122; Package: shipping box [20 Units]; In Commercial Distribution
GS1	07540184510122 [Package]; Package: carton box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152991

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-14
• Device Publish Date: 2016-09-24

On-Brand Devices [OptoWire]

• 00754018410121: Pressure guidewire
• 07540184110124: Pressure guidewire
• 07540184010325: Pressure guidewire