B-scan Plus Software Package: Veterinary Version

GUDID 00897826002192

ACCUTOME, INC.

Ophthalmic ultrasound imaging system

• Primary Device ID: 00897826002192
• NIH Device Record Key: e993d83f-e778-433c-b1f0-c07764423f9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-scan Plus Software Package: Veterinary Version
• Version Model Number: 1.03.03-U
• 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	00897826002192 [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: 4
• Public Version Date: 2021-11-29
• Device Publish Date: 2016-09-23

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
• 00897826002086 - AccuTip Cover: 2021-11-29 Individually wrapped