ISI

Basic Information

• Brand Name: ISI
• Primary DI: 00810045920955
• Version / Model: DigiGrip
• Catalog Number: DG-7550 SA
• Company Name: INSTRUMENT SPECIALISTS, INC.
• Labeler DUNS: 041517095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-23
• Public Version: 1
• Public Version Date: 2020-07-31
• Public Version Status: New
• Public Device Record Key: bed6e61a-2913-4ac4-82e7-6bac1c321fc5

Device Description

DigiGrip Vertical Traction System - Surgical Advantage

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILZ	Accessories, Traction	Physical Medicine	890.5925	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62639	Upper-limb traction wrap/trap, reusable	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 metal or synthetic polymer materials (e.g., nylon) with self-retaining fasteners (e.g., Velcro), and may be used with a traction arm band and/or malleable metal stave which acts as the anchor to the traction frame; some types may be inflatable to provide grip by means of air pressure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810045920955	GS1