OsteoMed

Basic Information

• Brand Name: OsteoMed
• Primary DI: 00842528110911
• Version / Model: 299-9000
• Catalog Number: 299-9000
• Company Name: OSTEOMED LLC
• Labeler DUNS: 606417780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-08
• Public Version: 1
• Public Version Date: 2019-11-18
• Public Version Status: New
• Public Device Record Key: 0a7ff105-2327-418b-a58f-7bdb5f3d10a8

Device Description

QuickFix MMF Plate

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: Yes
• PM Exempt: No
• 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
KCT	Sterilization wrap containers, trays, cassettes & other accessories	General Hospital	880.6850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41397	Orthodontic archwire	A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842528110911	GS1

Customer Contacts

• Phone: [phone] ext. 1
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	117	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Stored at controlled room temperature