Skytron

Basic Information

• Brand Name: Skytron
• Primary DI: 10841736123116
• Version / Model: 3-040-22
• Catalog Number: 3-040-22
• Company Name: SKYTRON LLC
• Labeler DUNS: 078375583
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• 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: 90bb6cb0-827b-4c22-8c51-b5a14d72e78f

Device Description

Head & chin straps, 12 ea. per case

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: 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
FQO	TABLE, OPERATING-ROOM, AC-POWERED	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44851	Limb/torso/head restraint, single-use	A non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00841736123140	GS1
Primary	10841736123116	GS1

Customer Contacts

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

Storage Conditions

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