IntraVu Scope 120 IV-ASY-1120

GUDID 00865351000341

Kit containing 120mm Scope and 120mm Cannula, 120mm Trocar, and Stopcock. IntraVu Scope is a miniaturized, sterile, single-use disposable scope for use with the IntraVu Tablet reusable video processing unit.

INTRAVU, INC.

Rigid arthroscope, single-use

• Primary Device ID: 00865351000341
• NIH Device Record Key: 51f83d38-138c-47c0-ac4e-4c597626306b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntraVu Scope 120
• Version Model Number: IV-ASY-1120
• Catalog Number: IV-ASY-1120
• Company DUNS: 116708692
• Company Name: INTRAVU, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com
• Phone: 18774977705
• Email: ProductInfo@IntraVuMedical.com

Device Dimensions

• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865351000341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181982

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-10
• Device Publish Date: 2019-12-02

Devices Manufactured by INTRAVU, INC.

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