Parkell®

Basic Information

• Brand Name: Parkell®
• Primary DI: 00810000527571
• Version / Model: S446
• Catalog Number: S446
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-03
• Public Version: 3
• Public Version Date: 2023-09-27
• Public Version Status: Update
• Public Device Record Key: d902a05b-53ab-43ca-a46a-989641d738cb
• Distribution End Date: 2023-03-31

Device Description

VPS Tray Adhesive

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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBH	Material, Impression Tray, Resin	Dental	872.3670	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16658	Dental impression material adhesive	A liquid material specifically made to give adhesion of an impression material to the impression tray. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810000527571	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep container tightly closed and store in a cool, dry and well-ventilated place.