uNion Cervical Plate System UM102-02-32

GUDID 00814386020138

Standard Cervical Plate, 2-Level, 32mm

Ulrich Medical Usa, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00814386020138
• NIH Device Record Key: 126928da-a8a0-44b6-aed7-8021f6f8ec4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uNion Cervical Plate System
• Version Model Number: UM102-02-32
• Catalog Number: UM102-02-32
• Company DUNS: 624083866
• Company Name: Ulrich Medical Usa, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814386020138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150666

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

Moist Heat or Steam Sterilization

[00814386020138]

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: 2016-01-29

On-Brand Devices [uNion Cervical Plate System]

• 00814386021654: Temporary Fixation Screw
• 00814386021647: Drill, 2.5 x 20mm
• 00814386021630: Drill, 2.5 x 18mm
• 00814386021623: Drill, 2.5 x 16mm
• 00814386021616: Drill, 2.5 x 14mm
• 00814386021609: Drill, 2.5 x 12mm
• 00814386021593: Drill, 2.5 x 10mm
• 00814386021586: Plate Holder - Inner Connection
• 00814386021579: Awl Sleeve
• 00814386021562: 2.5 Hex Screwdriver Shaft, Tapered Tip
• 00814386021555: 2.5 Hex Screwdriver Shaft, Split Tip
• 00814386021548: Jeweler Handle
• 00814386021531: Static Handle
• 00814386021524: Ratcheting Handle
• 00814386021517: Plate Holder - Outer Connection
• 00814386021500: Plate Bender
• 00814386021494: Dual Drill Guide
• 00814386021487: Fixed Drill Guide
• 00814386021470: Variable Drill Guide
• 00814386021463: Awl
• 00814386021456: Implant Module #7 Screw Caddy - 10mm & 20mm Screws
• 00814386021449: Implant Module #6 Screw Caddy - 4.0 Self Tapping & Self Drilling & 4.5mm
• 00814386021432: Implant Module #5 Screw Caddy - 4.0 Combo Self Drill/Tapping & 4.5mm Screws
• 00814386021425: Implant Module #4 - 1&2 Level Midline Plates
• 00814386021418: Implant Module #3 - 4 Level Standard Plates
• 00814386021401: Implant Module #2 - 3 Level Standard Plates
• 00814386021395: Implant Module #1 - 1&2 Level Standard Plates
• 00814386021388: Implant Tray Lid
• 00814386021371: Implant Tray - Top Layer
• 00814386021364: Outer Base
• 00814386021357: Lid
• 00814386021340: Lid Module #7 - 10mm and 20mm Screw Lengths
• 00814386021333: Lid Module #6 - 4.0 Self-Tapping and Self-Drilling & 4.5mm Screws
• 00814386021326: Lid Module #5 - 4.0 Combo Self Drill/Tapping & 4.5mm Screws
• 00814386021319: Lid Module #4 - 1&2 Level Midline Plates
• 00814386021302: Lid Module #3 - 4 Level Standard Plates
• 00814386021296: Lid Module #2 - 3 Level Standard Plates
• 00814386021289: Lid Module #1 - 1&2 Level Standard Plates
• 00814386021272: Rescue Self-Drilling/Self-Tapping Variable Screw, Dark Blue, 4.5x20mm
• 00814386021265: Rescue Self-Drilling/Self-Tapping Variable Screw, Light Blue, 4.5x18mm
• 00814386021258: Rescue Self-Drilling/Self-Tapping Variable Screw, Gold, 4.5x16mm
• 00814386021241: Rescue Self-Drilling/Self-Tapping Variable Screw, Magenta, 4.5x14mm
• 00814386021234: Rescue Self-Drilling/Self-Tapping Variable Screw, Dark Blue, 4.5x12mm
• 00814386021227: Rescue Self-Drilling/Self-Tapping Variable Screw, Green, 4.5x10mm
• 00814386021210: Self-Drilling/Self-Tapping Variable Screw, Dark Blue, 4.0x20mm
• 00814386021203: Self-Drilling/Self-Tapping Variable Screw, Light Blue, 4.0x18mm
• 00814386021197: Self-Drilling/Self-Tapping Variable Screw, Gold, 4.0x16mm
• 00814386021180: Self-Drilling/Self-Tapping Variable Screw, Magenta, 4.0x14mm
• 00814386021173: Self-Drilling/Self-Tapping Variable Screw, Dark Blue, 4.0x12mm
• 00814386021166: Self-Drilling/Self-Tapping Variable Screw, Green, 4.0x10mm