30 SideVu-90 IV-ASY-3090

GUDID 00850023905048

Kit containing 90mm Scope and 90mm Cannula (2x), 90mm Trocar (2x), and Stopcock (2x). 30 SideVu is a 30deg miniaturized, sterile, single-use, disposable scope for use with the TabletVu reusable video processing unit.

INTRAVU, INC.

Rigid arthroscope, single-use

• Primary Device ID: 00850023905048
• NIH Device Record Key: a5fdf566-a916-49ab-878c-06f6aec06d77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 30 SideVu-90
• Version Model Number: IV-ASY-3090
• Catalog Number: IV-ASY-3090
• 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: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com
• Phone: 18774977705
• Email: Productlnfo@lntraVu.com

Device Dimensions

• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850023905048 [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: 2023-07-11
• Device Publish Date: 2023-07-03

Devices Manufactured by INTRAVU, INC.

• 00850023905031 - 30 SideVu-60: 2023-07-11 Kit containing 60mm Scope and 60mm Cannula (2x), 60mm Trocar (2x), and Stopcock (2x). 30 SideVu is a 30deg miniaturized, sterile
• 00850023905048 - 30 SideVu-90: 2023-07-11Kit containing 90mm Scope and 90mm Cannula (2x), 90mm Trocar (2x), and Stopcock (2x). 30 SideVu is a 30deg miniaturized, sterile, single-use, disposable scope for use with the TabletVu reusable video processing unit.
• 00850023905048 - 30 SideVu-90: 2023-07-11 Kit containing 90mm Scope and 90mm Cannula (2x), 90mm Trocar (2x), and Stopcock (2x). 30 SideVu is a 30deg miniaturized, sterile
• 00850023905055 - 30 SideVu-120: 2023-07-11 Kit containing 120mm Scope and 120mm Cannula (2x), 120mm Trocar (2x), and Stopcock (2x). 30 SideVu is a 30deg miniaturized, ster
• 00850023905000 - AccessVu 90: 2021-10-25 Disposable accessory kit to be used with IntraVu Scope 90. Kit contains 90mm cannula, 90mm trocar, cannula cap and stopcock.
• 00850023905017 - AccessVu 60: 2021-10-25 Disposable accessory kit to be used with IntraVu Scope 60. Kit contains 60mm cannula, 60mm trocar, cannula cap and stopcock.
• 00850023905024 - AccessVu 120: 2021-10-25 Disposable accessory kit to be used with IntraVu Scope 120. Kit contains 120mm cannula, 120mm trocar, cannula cap and stopcock.
• 00865351000389 - TabletVu: 2021-10-25 TabletVu is a reusable visualization system for use with the IntraVu Scope.
• 00865351000303 - MIDAScope™ - 120 and Introducer Kit: 2020-03-27 Kit containing 120mm Scope and 120mm Cannula, 120mm Trocar, and Stopcock. MIDAScope™ is a miniaturized, sterile, single-use di