Parkell®

Basic Information

• Brand Name: Parkell®
• Primary DI: 10810000527554
• Version / Model: S276
• Catalog Number: S276
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2018-10-19
• Public Version: 3
• Public Version Date: 2024-01-29
• Public Version Status: Update
• Public Device Record Key: 91c96e37-29a0-48b7-b4dc-9d0476c1eff0
• Distribution End Date: 2023-04-18

Device Description

Parkell® Etching Gel

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: No
• 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
EMA	Cement, Dental	Dental	872.3275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36153	Dental etching solution	An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. 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	10810000527554	GS1
Unit of Use	00810000527557	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store the product tightly sealed, away from direct sunlight, exxtreme cold or high heat. Refrigeration is acceptable but not essential; bring chilled material to room temperature before use. Do not st