HADRON FPLS INFINITY GEN 3.0

Basic Information

• Brand Name: HADRON FPLS INFINITY GEN 3.0
• Primary DI: 00860003986813
• Version / Model: FPLS-3000-PAD
• Catalog Number: FPLS-3000-PAD
• Company Name: Infinitus Medical Technologies LLC
• Labeler DUNS: 079575412
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-16
• Public Version: 1
• Public Version Date: 2024-07-24
• Public Version Status: New
• Public Device Record Key: a5261b1b-4b29-4f71-83fb-4ab8f605eb9c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
CCX	Support, Patient Position	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65178	Operating table patient positioning set, single-use	A collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent patient sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: padded positioners dedicated to a body part such as arm, leg, shoulder, neck, or feet positioner, a headrest, a non-slip pad/bolster placed underneath the patient (e.g., cervical notch), and securing devices (e.g., straps). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003986813	GS1