3-in-1 SHAVER™ 5.0mm R-10014

GUDID 08592730070146

Multi-functional shaver blade, disposable

RELIGN CORPORATION

Orthopaedic bur, single-use

• Primary Device ID: 08592730070146
• NIH Device Record Key: aa35771d-3768-475c-a459-23727c425e9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3-in-1 SHAVER™ 5.0mm
• Version Model Number: R-10014
• Catalog Number: R-10014
• 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 Dimensions

• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08592730070146 [Primary]
GS1	18592730070143 [Package]; Package: Shelf Box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162770

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: 2019-07-05
• Device Publish Date: 2019-06-27

On-Brand Devices [3-in-1 SHAVER™ 5.0mm]

• 08592730070146: Multi-functional shaver blade, disposable
• 10859273007141: Multi-functional shaver blade, disposable