Top Shelf Orthopedics

Basic Information

• Brand Name: Top Shelf Orthopedics
• Primary DI: 00850016589019
• Version / Model: 530002
• Catalog Number: 530002
• Company Name: Top Shelf Manufacturing, LLC
• Labeler DUNS: 114134625
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-18
• Public Version: 2
• Public Version Date: 2023-11-29
• Public Version Status: Update
• Public Device Record Key: 6adb8a63-7dc9-4c3f-9bd2-0e1d9ca60574

Device Description

Standard Sleeve, Sterile

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KQZ	Component, Traction, Non-Invasive	Orthopedic	888.5890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62638	Upper-limb traction wrap/trap, single-use	A preformed device designed to encompass the fingers, hand or forearm to create a holder which can be attached to an external frame to provide traction/suspension of the upper limb during surgical procedures on the hand, arm or shoulder. It is typically made of synthetic polymer textile (e.g., nylon) and includes self-retaining fasteners (e.g., Velcro); it may be used with a traction arm band and/or malleable metal stave which acts as the anchor to the traction frame. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850016589016	GS1		6	In Commercial Distribution
Primary	00850016589019	GS1

Customer Contacts

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