Pegasus

GUDID 00857915007415

Pegasus Wireless Receiver

A.M. SURGICAL, INC.

Endoscopic control/video-imaging system

• Primary Device ID: 00857915007415
• NIH Device Record Key: f5f15973-27b9-4ed5-b3cb-8201963689aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pegasus
• Version Model Number: 1001
• Company DUNS: 160020087
• Company Name: A.M. SURGICAL, 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

Customer Support Contacts

• Phone: 6319799777
• Email: service@amsurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857915007415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191345

FDA Product Code

• HRX: Arthroscope

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: 2019-08-07
• Device Publish Date: 2019-07-30

On-Brand Devices [Pegasus]

• 00857915007415: Pegasus Wireless Receiver
• 00857915007408: Pegasus Wireless Endoscopy System - Single Use Arthroscope