BodyFIX

Basic Information

• Brand Name: BodyFIX
• Primary DI: 04056719001728
• Version / Model: P10102-305
• Catalog Number: P10102-305
• Company Name: 3C-Medical Intelligence GmbH
• Labeler DUNS: 314546664
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-23
• Public Version: 5
• Public Version Date: 2023-12-15
• Public Version Status: Update
• Public Device Record Key: f77fa640-8aa0-4cf1-aa3a-546da1bb170c

Device Description

BodyFIX® Hygienic Drape Manifold Tube (2x15000mm) is used to cover the manifold tube for hygienic purposes.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40895	Vacuum-mould patient positioning system	An assembly of devices designed to apply a vacuum to a cushion or bag filled with foam-like material that is placed under, on, or around a patients body parts. A vacuum is applied to the contents of the cushion forming a patient specific (custom-made) mould. The moulds can be whole body or selected body parts and help ensure adequate positioning and immobilization of the patient during diagnostic imaging and/or radiation therapy procedures facilitating reproducible positioning for serial procedures. This system typically includes reusable foam-filled bags, cushions, a vacuum unit, hardware, seals, and interfaces used to connect the mould to another patient positioning system (PPS).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04056719000264	GS1		5	In Commercial Distribution
Primary	04056719001728	GS1

Premarket Submissions

Submission Number	Supplement Number
K121530	000