Polygon

GUDID 10860001020608

Polygon Resection Device - 9Fr/3 mm

POLYGON MEDICAL INC

Tissue morcellation system

• Primary Device ID: 10860001020608
• NIH Device Record Key: be0e24da-3e86-43c9-8efa-c4963acbab8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polygon
• Version Model Number: 50-100
• Company DUNS: 093634445
• Company Name: POLYGON MEDICAL 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: 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: 7758007300
• Email: ron.adams2006@gmail.com

Device Dimensions

• Outer Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001020601 [Primary]
GS1	00861000102060 [Primary]
GS1	10860001020608 [Package]; Contains: 00860001020601; Package: Case [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182675

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-08-16
• Device Publish Date: 2019-06-03