traxi® Panniculus Retractor

GUDID 20814247020349

Traxi Panniculus Retractor with Retentus Technology (BMI 30-50)

CLINICAL INNOVATIONS, LLC

Abdominal retractor, hand-held

• Primary Device ID: 20814247020349
• NIH Device Record Key: bc0b5e29-71cb-4bdb-a68d-5c24c5efc9de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: traxi® Panniculus Retractor
• Version Model Number: PRS-1030
• Company DUNS: 809524291
• Company Name: CLINICAL INNOVATIONS, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814247020345 [Primary]
GS1	10814247020342 [Package]; Contains: 00814247020345; Package: [10 Units]; In Commercial Distribution
GS1	20814247020349 [Package]; Contains: 10814247020342; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• CCX: Support, Patient Position

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-01

On-Brand Devices [traxi® Panniculus Retractor]

• 00814247020802: Traxi Panniculus Retractor with Retentus Technology
• 20814247020349: Traxi Panniculus Retractor with Retentus Technology (BMI 30-50)