Skytron

Basic Information

• Brand Name: Skytron
• Primary DI: 10841736123369
• Version / Model: 4-090-17-2
• Catalog Number: 4-090-17-2
• Company Name: SKYTRON LLC
• Labeler DUNS: 078375583
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-29
• Public Version: 1
• Public Version Date: 2022-02-07
• Public Version Status: New
• Public Device Record Key: c9e8661a-43c2-4597-808e-366bde47750f

Device Description

Versa Fit Elite Boot (sold as a pair)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: Yes
• Has Serial Number: Yes
• 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
FQO	TABLE, OPERATING-ROOM, AC-POWERED	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55836	Leg procedure positioner	A preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure). It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841736123369	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius