Preat

Basic Information

• Brand Name: Preat
• Primary DI: 00842092155707
• Version / Model: 0800149
• Catalog Number: 0800149
• Company Name: Preat Corporation
• Labeler DUNS: 117776048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-24
• Public Version: 4
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: 1c48edb2-d185-40ca-a614-c6b896ffdcf8

Device Description

Screw Extractor Kit Internal Hex 3i Certain 3.4mm. Kit contains:. 1 Claw Reamer Bur Internal Hex 3i Certain 3.4mm (00842092125595). 1 Reverse Cutting Bur External Hex 3i/Branemark (00842092139233). 1 Centering Device (00842092155684)

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
NDP	Accessories, implant, dental, endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61030	Screw extractor, single-use	A hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical 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	00842092155707	GS1

Customer Contacts

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