Dynablator™ R-10005

GUDID 10859273007059

RF probe, disposable

RELIGN CORPORATION

Endoscopic electrosurgical electrode, bipolar, single-use

• Primary Device ID: 10859273007059
• NIH Device Record Key: 419817b5-9cf2-4b55-ad0e-c0b061bf810e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynablator™
• Version Model Number: R-10005
• Catalog Number: R-10005
• 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
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com
• Phone: (866) 608-0131
• Email: customer.service@religncorp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859273007052 [Primary]
GS1	08592730070054 [Previous]
GS1	10859273007059 [Package]; Contains: 00859273007052; Package: Shelf Box [4 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: 2020-02-28
• Device Publish Date: 2020-02-20

Devices Manufactured by RELIGN CORPORATION

• 10859273007257 - Curved Standard Ball Burr XL 5.0 mm: 2022-06-24 Standard burr, disposable
• 10859273007264 - Curved Standard Shaver XL 4.2 mm: 2022-06-24 Standard shaver blade, disposable
• 10859273007127 - Standard Shaver 3.4mm: 2021-03-15 Standard shaver blade, disposable
• 10859273007240 - Curved Standard Shaver 3.4mm: 2021-03-15 Standard shaver blade, disposable
• 00859273007212 - Standard Burr 5.0mm: 2020-10-22 Standard burr, disposable
• 00859273007236 - Tricera™ Handpiece, Autoclavable: 2020-08-28 Shaver Handpiece, Autoclavable
• 10859273007080 - 3-in-1 SHAVER™ 4.2mm: 2020-07-27 Multi-functional shaver blade, disposable
• 00859273007014 - Tricera™ Controller: 2020-02-28 System Controller with Footswitch