Expandex™

Basic Information

• Brand Name: Expandex™
• Primary DI: 10810000526779
• Version / Model: S226
• Catalog Number: S226
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2019-04-05
• Public Version: 4
• Public Version Date: 2022-11-07
• Public Version Status: Update
• Public Device Record Key: 107ba9fe-b8c9-4207-b706-1586263bced3
• Distribution End Date: 2022-09-30

Device Description

Adult Expandex™ (Pkg. of 2 pcs.)

Device Characteristics

• Single Use: No
• 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: 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
EIG	Retractor, All Types	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44827	Dental dry field kit	A collection of devices and supplies used in orthodontic and restorative dentistry to maintain a dry oral cavity for treatment procedures. It provides the operator with easy access to the field of operation by holding the mouth open, displacing the tongue, and removing saliva during various procedures (e.g., bonding orthodontic brackets, bleaching, applying veneers or pit and fissure sealants, posterior restorations). It typically consists of bite blocks, pad extenders, suction tips of varying sizes, and tubing that connects to a suction system. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810000526779	GS1
Unit of Use	00810000526772	GS1

Customer Contacts

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