4Sight 24-8000

GUDID 00897826002079

ACCUTOME, INC.

Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter

• Primary Device ID: 00897826002079
• NIH Device Record Key: bb04a165-fb4b-4388-ba38-4e26bf452452
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4Sight
• Version Model Number: 24-8000
• Catalog Number: 24-8000
• Company DUNS: 048792816
• Company Name: ACCUTOME, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00897826002079 [Primary]

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-11-29
• Device Publish Date: 2016-09-13

Devices Manufactured by ACCUTOME, INC.

• 00897826002000 - Accupen: 2021-11-29
• 00897826002017 - Pachpen: 2021-11-29
• 00897826002024 - A-scan Plus Connect: 2021-11-29
• 00897826002031 - B-scan Plus: 2021-11-29
• 00897826002055 - Accupach VI: 2021-11-29
• 00897826002062 - B-scan Pro: 2021-11-29
• 00897826002079 - 4Sight: 2021-11-29
• 00897826002079 - 4Sight: 2021-11-29
• 00897826002086 - AccuTip Cover: 2021-11-29 Individually wrapped