FR Attachments

Basic Information

• Brand Name: FR Attachments
• Primary DI: 00842092110669
• Version / Model: 0702040
• Catalog Number: 0702040
• Company Name: Preat Corporation
• Labeler DUNS: 117776048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-05
• Public Version: 3
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: c3bf88f9-d390-4730-b655-bfe2d566b595

Device Description

FR Silicone Male

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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
EGG	Attachment, Precision, All	Dental	872.3165	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38603	Resilient dental precision attachment	A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00842092174579	GS1	Pack	12	Not in Commercial Distribution	2024-02-16
Primary	00842092110669	GS1
Package	00842092174586	GS1	Pack	6	In Commercial Distribution

Customer Contacts

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