Skytron

Basic Information

• Brand Name: Skytron
• Primary DI: 10841736116842
• Version / Model: 3-060-09-2
• Catalog Number: 3-060-09-2
• 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: ba341aa6-34ba-4573-bc74-44d1e97a05a0

Device Description

G-Series 5 Inch Side Ext. Back Section (Right)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
65180	Operating table patient positioning set, reusable	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 a patient from sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: a base plate/bar that serves as a foundation to which patient positioners are attached, clamps/adaptors, and disposable/reusable padded positioners dedicated to a body part (e.g., non-slip positioning pad, headrest). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841736116842	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	18.25	Inch

Storage Conditions

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