PRO3DURE GR-21 Try-In

Basic Information

• Brand Name: PRO3DURE GR-21 Try-In
• Primary DI: EPRCD1001602
• Version / Model: 1kg ; Color:A2
• Catalog Number: D1001602
• Company Name: pro3dure medical GmbH
• Labeler DUNS: 312947842
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-12
• Public Version: 1
• Public Version Date: 2022-09-20
• Public Version Status: New
• Public Device Record Key: b0334509-b547-4fd0-828e-5a9e9f375137

Device Description

printodent GR-21 Try-In 1kg ; Color:A2

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EEA	Plate, Base, Shellac	Dental	872.6200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34808	Dental base plate	A foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EPRCD1001602	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight