StimSite AM 100

GUDID 00860002926902

Signal Box, StimSite

Allotrope Medical Inc.

Nerve-locating system

• Primary Device ID: 00860002926902
• NIH Device Record Key: 9ce6bbba-abc9-4686-9583-0bf22ca3748d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StimSite
• Version Model Number: AM 100
• Catalog Number: AM 100
• 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: 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	00860002926902 [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: 2022-11-26

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