Implant Prosthetics

Basic Information

• Brand Name: Implant Prosthetics
• Primary DI: 00842092134641
• Version / Model: 9000203-10
• Catalog Number: 9000203-10
• Company Name: Preat Corporation
• Labeler DUNS: 117776048
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-28
• Public Version: 6
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: f4b33916-58a5-4186-851d-8316052aa772
• Distribution End Date: 2023-08-11

Device Description

Zimmer® TSV-compatible 4.5mm Digital Analog (10-Pack)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZA	DRILL, DENTAL, INTRAORAL	Dental	872.4130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31868	Dental laboratory mandrel	A round shaft of substantial dimensions designed to be used in the dental laboratory to hold (locked into place) a rotating device, e.g., a grinding or polishing wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing; connectors and rotating endpieces may be included with the device. The mandrel will be placed into a laboratory dental handpiece or lathe that will rotate at high speed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842092134641	GS1

Customer Contacts

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