traxi® Panniculus Retractor Extender

GUDID 20814247020363

Traxi Extender (BMI>50 - used with PH-25)

CLINICAL INNOVATIONS, LLC

Abdominal retractor, hand-held

• Primary Device ID: 20814247020363
• NIH Device Record Key: 99e85103-bd4a-4425-9dab-a497696fbac5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: traxi® Panniculus Retractor Extender
• Version Model Number: PRS-1050
• 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	00814247020369 [Primary]
GS1	10814247020366 [Package]; Contains: 00814247020369; Package: [10 Units]; In Commercial Distribution
GS1	20814247020363 [Package]; Contains: 10814247020366; 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 Extender]

• 20814247020363: Traxi Extender (BMI>50 - used with PH-25)
• 30814247020360: Traxi Extender with Retentus Technology (BMI>50 - used with PH-25)