Exoflow™ R-10017

GUDID 18592730070174

Fluid management accessory disposable, outflow only

RELIGN CORPORATION

Surgical irrigation/aspiration tubing set

• Primary Device ID: 18592730070174
• NIH Device Record Key: b0ecc14c-38ba-41bf-b9e1-63b499b8ce69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exoflow™
• Version Model Number: R-10017
• Catalog Number: R-10017
• Company DUNS: 080031617
• Company Name: RELIGN CORPORATION
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (866) 608-0131
• Email: customer.service@religncorp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08592730070177 [Primary]
GS1	18592730070174 [Package]; Contains: 08592730070177; Package: Customer Shipper Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162770

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2019-06-20
• Device Publish Date: 2019-06-12

On-Brand Devices [Exoflow™]

• 18592730070174: Fluid management accessory disposable, outflow only
• 10859273007172: Fluid management accessory disposable, outflow only