UniVise IS4143UNI

GUDID 07613327281163

Specialty Spinous Process Distractor

Stryker Corporation

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 07613327281163
• NIH Device Record Key: 798185d4-dd6d-4670-92b1-7257b8e0866c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniVise
• Version Model Number: IS4143UNI
• Catalog Number: IS4143UNI
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327281163 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[07613327281163]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-11
• Device Publish Date: 2018-09-10

On-Brand Devices [UniVise]

• 07613327281163: Specialty Spinous Process Distractor
• 07613327065657: SPINOUS PROCESS FIXATION PLATE
• 07613327065640: SPINOUS PROCESS FIXATION PLATE