Parkell®

Basic Information

• Brand Name: Parkell®
• Primary DI: 10810000527561
• Version / Model: S379
• Catalog Number: S379
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2019-08-16
• Public Version: 4
• Public Version Date: 2023-12-22
• Public Version Status: Update
• Public Device Record Key: d6235c22-56d7-4f5e-8276-b92bdbd4385c

Device Description

Adjustable Precision Applicators (4 Pkg. of 50 pcs.)

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	880.6025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810000527561	GS1
Unit of Use	00810000527564	GS1

Customer Contacts

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