Pegasus

GUDID 00857915007408

Pegasus Wireless Endoscopy System - Single Use Arthroscope

A.M. SURGICAL, INC.

Rigid arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use

• Primary Device ID: 00857915007408
• NIH Device Record Key: 4380a7b7-3968-4d4f-8c70-052796cb92e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pegasus
• Version Model Number: 1000
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857915007408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191345

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-08
• Device Publish Date: 2019-07-31

On-Brand Devices [Pegasus]

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