Head-Up-Display, HUD-1 SA-06427

GUDID 00855005006218

Head-Up-Display, HUD-1, Ophthalmic Projector

TOPCON MEDICAL LASER SYSTEMS, INC.

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• Primary Device ID: 00855005006218
• NIH Device Record Key: b75bdf6c-8aeb-4be5-8ba3-235b87a05574
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Head-Up-Display, HUD-1
• Version Model Number: Head-Up-Display,HUD-1
• Catalog Number: SA-06427
• Company DUNS: 041376321
• Company Name: TOPCON MEDICAL LASER SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855005006218 [Primary]

FDA Product Code

• HOS: Projector, ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-18
• Device Publish Date: 2018-02-12

Devices Manufactured by TOPCON MEDICAL LASER SYSTEMS, INC.

• 00855005006232 - PASCAL Synthesis TwinStar: 2019-11-18 PASCAL Synthesis TwinStar (577/638), PA-04 (PACKED)
• 00855005006249 - PACSAL Synthesis: 2019-11-18 PASCAL Synthesis (532), Green, PA-04 (PACKED)
• 00855005006256 - PASCAL Synthesis: 2019-11-18 PASCAL Synthesis (577), Yellow, PA-04 (PACKED)
• 00855005006263 - PASCAL Synthesis TwinStar: 2019-11-18 PASCAL Synthesis TwinStar (577/638), PA-04, JAPAN (PACKED)
• 00855005006270 - PACSAL Synthesis: 2019-11-18 PASCAL Synthesis (532), Green, PA-04, JAPAN (PACKED)
• 00855005006287 - PACSAL Synthesis: 2019-11-18 PASCAL Synthesis (577), Yellow, PA-04, JAPAN (PACKED)
• 00855005006003 - PASCAL Synthesis: 2019-11-18 (532) PASCAL, SYNTHESIS III CONSOLE (PACKED) A1 RELEASE
• 00855005006010 - PASCAL Synthesis: 2019-11-18 (577) PASCAL, SYNTHESIS III CONSOLE (PACKED) A1 RELEASE