Reliance Buttress Washer System 8-02-020

GUDID 00842566106945

Buttress Washer Staple, 20mm

RELIANCE MEDICAL SYSTEMS, LLC

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00842566106945
• NIH Device Record Key: a84d64aa-79a6-417a-b5cf-126311a08b5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reliance Buttress Washer System
• Version Model Number: 8-02-020
• Catalog Number: 8-02-020
• Company DUNS: 064885444
• Company Name: RELIANCE MEDICAL SYSTEMS, LLC
• 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: false
• 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: 801-295-3280
• Email: info@reliance-medical.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842566106945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073349

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00842566106945]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-09

On-Brand Devices [Reliance Buttress Washer System ]

• 00842566106969: Buttress Washer Screw 4.5x30mm
• 00842566106952: Buttress Washer Screw 4.5x25mm
• 00842566106945: Buttress Washer Staple, 20mm
• 00842566106938: Buttress Washer-Narrow, 20mm