Reliance Anterior Cervical Plate System 4-01-018U

GUDID 00842566102367

RACP Single Level Plate, 18, Unassembled

RELIANCE MEDICAL SYSTEMS, LLC

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00842566102367
• NIH Device Record Key: 62502c73-1c72-4a5f-b931-5d9e0b9bdb53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reliance Anterior Cervical Plate System
• Version Model Number: 4-01-018U
• Catalog Number: 4-01-018U
• 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
• Phone: 801-295-3280
• Email: info@reliance-medical.net
• Phone: 801-295-3280
• Email: info@reliance-medical.net
• Phone: 801-295-3280
• Email: info@reliance-medical.net
• Phone: 801-295-3280
• Email: info@reliance-medical.net
• Phone: 801-295-3280
• Email: info@reliance-medical.net
• Phone: 801-295-3280
• Email: info@reliance-medical.net
• Phone: 801-295-3280
• Email: info@reliance-medical.net
• Phone: 801-295-3280
• Email: info@reliance-medical.net
• Phone: 801-295-3280
• Email: info@reliance-medical.net
• Phone: 801-295-3280
• Email: info@reliance-medical.net
• Phone: 801-295-3280
• Email: info@reliance-medical.net
• Phone: 801-295-3280
• Email: info@reliance-medical.net
• Phone: 801-295-3280
• Email: info@reliance-medical.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842566102367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140742

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00842566102367]

Moist Heat or Steam Sterilization

[00842566102367]

Moist Heat or Steam Sterilization

[00842566102367]

Moist Heat or Steam Sterilization

[00842566102367]

Moist Heat or Steam Sterilization

[00842566102367]

Moist Heat or Steam Sterilization

[00842566102367]

Moist Heat or Steam Sterilization

[00842566102367]

Moist Heat or Steam Sterilization

[00842566102367]

Moist Heat or Steam Sterilization

[00842566102367]

Moist Heat or Steam Sterilization

[00842566102367]

Moist Heat or Steam Sterilization

[00842566102367]

Moist Heat or Steam Sterilization

[00842566102367]

Moist Heat or Steam Sterilization

[00842566102367]

Moist Heat or Steam Sterilization

[00842566102367]

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 Anterior Cervical Plate System]

• 00842566104163: RACP 4.5 Self-Tapping, Variable Screw, 18
• 00842566104156: RACP 4.5 Self-Tapping, Variable Screw, 16
• 00842566104149: RACP 4.5 Self-Tapping, Variable Screw, 14
• 00842566104132: RACP 4.5 Self-Tapping, Variable Screw, 12
• 00842566104125: RACP 4.5 Self-Tapping, Fixed Screw, 18
• 00842566104118: RACP 4.5 Self-Tapping, Fixed Screw, 16
• 00842566104101: RACP 4.5 Self-Tapping, Fixed Screw, 14
• 00842566104095: RACP 4.5 Self-Tapping, Fixed Screw, 12
• 00842566104088: RACP 4.5 Self-Drilling, Variable Screw, 18
• 00842566104071: RACP 4.5 Self-Drilling, Variable Screw, 16
• 00842566104064: RACP 4.5 Self-Drilling, Variable Screw, 14
• 00842566104057: RACP 4.5 Self-Drilling, Variable Screw, 12
• 00842566104040: RACP 4.5 Self-Drilling, Fixed Screw, 18
• 00842566104033: RACP 4.5 Self-Drilling, Fixed Screw, 16
• 00842566104026: RACP 4.5 Self-Drilling, Fixed Screw, 14
• 00842566104019: RACP 4.5 Self-Drilling, Fixed Screw, 12
• 00842566104002: RACP 4.25 Self-Tapping, Variable Screw, 18
• 00842566103999: RACP 4.25 Self-Tapping, Variable Screw, 16
• 00842566103982: RACP 4.25 Self-Tapping, Variable Screw, 14
• 00842566103975: RACP 4.25 Self-Tapping, Variable Screw, 12
• 00842566103968: RACP 4.25 Self-Tapping, Fixed Screw, 18
• 00842566103951: RACP 4.25 Self-Tapping, Fixed Screw, 16
• 00842566103944: RACP 4.25 Self-Tapping, Fixed Screw, 14
• 00842566103937: RACP 4.25 Self-Tapping, Fixed Screw, 12
• 00842566103920: RACP 4.25 Self-Drilling, Variable Screw, 18
• 00842566103913: RACP 4.25 Self-Drilling, Variable Screw, 16
• 00842566103906: RACP 4.25 Self-Drilling, Variable Screw, 14
• 00842566103890: RACP 4.25 Self-Drilling, Variable Screw, 12
• 00842566103883: RACP 4.25 Self-Drilling, Fixed Screw, 18
• 00842566103876: RACP 4.25 Self-Drilling, Fixed Screw, 16
• 00842566103869: RACP 4.25 Self-Drilling, Fixed Screw, 14
• 00842566103852: RACP 4.25 Self-Drilling, Fixed Screw, 12
• 00842566103845: RACP 4.0 Self-Tapping, Variable Screw, 18
• 00842566103838: RACP 4.0 Self-Tapping, Variable Screw, 16
• 00842566103821: RACP 4.0 Self-Tapping, Variable Screw, 14
• 00842566103814: RACP 4.0 Self-Tapping, Variable Screw, 12
• 00842566103807: RACP 4.0 Self-Tapping, Fixed Screw, 18
• 00842566103791: RACP 4.0 Self-Tapping, Fixed Screw, 16
• 00842566103784: RACP 4.0 Self-Tapping, Fixed Screw, 14
• 00842566103777: RACP 4.0 Self-Tapping, Fixed Screw, 12
• 00842566103760: RACP 4.0 Self-Drilling, Variable Screw, 18
• 00842566103753: RACP 4.0 Self-Drilling, Variable Screw, 16
• 00842566103746: RACP 4.0 Self-Drilling, Variable Screw, 14
• 00842566103739: RACP 4.0 Self-Drilling, Variable Screw, 12
• 00842566103722: RACP 4.0 Self-Drilling, Fixed Screw, 18
• 00842566103715: RACP 4.0 Self-Drilling, Fixed Screw, 16
• 00842566103708: RACP 4.0 Self-Drilling, Fixed Screw, 14
• 00842566103692: RACP 4.0 Self-Drilling, Fixed Screw, 12
• 00842566103685: RACP Five-Level Plate, 105
• 00842566103678: RACP Five-Level Plate, 100