4Sight 24-8000

GUDID 00897826002079

ACCUTOME, INC.

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