UniVise Spinous Process Fixation Plate System 48590140

GUDID 07613327123630

TRIAL

Stryker Corporation

Spinal implant trial

• Primary Device ID: 07613327123630
• NIH Device Record Key: ee7ca940-dc6d-4953-a2e6-1cfab5a5ca59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniVise Spinous Process Fixation Plate System
• Version Model Number: 48590140
• Catalog Number: 48590140
• Company DUNS: 149183167
• Company Name: Stryker Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Dimensions

• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327123630 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

[07613327123630]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-10
• Device Publish Date: 2019-12-02

On-Brand Devices [UniVise Spinous Process Fixation Plate System]

• 07613327123630: TRIAL
• 07613327121957: TRIAL
• 07613327121971: INSERTER INNER SHAFT
• 07613327121964: INSERTER