StimSite AM-LS1

GUDID 00860002926940

StimSite Ligasure Adapter

Allotrope Medical Inc.

Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system

• Primary Device ID: 00860002926940
• NIH Device Record Key: 769ca791-21b4-4b53-8eb7-274b98be7cf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StimSite
• Version Model Number: AM-LS1
• Catalog Number: AM-LS1
• Company DUNS: 080572607
• Company Name: Allotrope Medical Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	00860002926940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200886

FDA Product Code

• ETN: Stimulator, Nerve

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-05
• Device Publish Date: 2022-11-27

On-Brand Devices [StimSite]

• 00860002926957: StimSite Bipolar Adapter
• 00860002926940: StimSite Ligasure Adapter
• 00860002926933: StimSite Da Vinci Adapter
• 00860002926919: Activation Card, StimSite, Single
• 00860002926902: Signal Box, StimSite