Pink Petal

Basic Information

• Brand Name: Pink Petal
• Primary DI: 10840161307092
• Version / Model: 50Z975SMPL
• Company Name: ZIRC DENTAL PRODUCTS, INC.
• Labeler DUNS: 064783913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2022-10-07
• Public Version: 1
• Public Version Date: 2022-10-17
• Public Version Status: New
• Public Device Record Key: a0c4e3a4-59ca-46db-b6a4-b92d630150ce

Device Description

Pink Petal Sample Pack, qty 2

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DYN	Mouthpiece, Saliva Ejector	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63670	Intraoral dental suction tip holder	A non-sterile semi-flexible device intended to be attached to the distal end of a dental suction tip and held between the teeth and cheek of a patient, to allow for hands-free suction during a dental procedure. It is typically a flat disk made of synthetic polymer materials with a clip/loop for attachment to the suction tip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10840161307092	GS1
Unit of Use	00840161307095	GS1

Device Sizes

Type	Value	Unit	Text
Length	15.9	Centimeter
Width	12.7	Centimeter