Poly Mixing Pads with Foam

Basic Information

• Brand Name: Poly Mixing Pads with Foam
• Primary DI: 00616784447322
• Version / Model: 4473
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2021-06-21
• Public Version: 2
• Public Version Date: 2023-05-04
• Public Version Status: Update
• Public Device Record Key: c8ec1a83-ec5b-401a-ac6e-50aa3f700ba9

Device Description

Poly Mixing Pads with Foam Back- (poly 2 side), 3"x3", Poly-coated, 100 sheets per pad

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZN	Instruments, Dental Hand	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44999	Dental material mixing surface, chairside, single-use	A pad, tray, well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00616784447339	GS1	Case	6	In Commercial Distribution
Primary	00616784447322	GS1
Unit of Use	00616784447315	GS1