Hader

Basic Information

• Brand Name: Hader
• Primary DI: 00842092155455
• Version / Model: 0101746
• Catalog Number: 0101746
• Company Name: Preat Corporation
• Labeler DUNS: 117776048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-25
• Public Version: 4
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: e0995bc0-603b-4fdb-82d9-c804c5d312b1

Device Description

Hader Bar Alignment Servicing Kit. Kit contains . 2 Hader Yellow Riders-Standard (00842092105337). 1 Hader Insertion Tool (00842092105504). 2 Hader Alignment Housings (00842092105320). 2 Hader Green Processing Spacers (00842092105375). 1 Hader White Delrin Analog (00842092105412)

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: Yes
• 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: Yes
• 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
17845	Partial denture	A custom-made, removeable, artificial replacement for one or more, but not all, teeth in the lower or upper jaw (mandible or maxilla) in a partially edentulous patient. It typically includes clasps of metal or plastic that clip onto remaining teeth for retention and stabilization. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)]. Also known as a removable partial denture (RPD).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842092155455	GS1

Customer Contacts

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