MARA Ext.Lower Stop Ctr(10Pk)

Basic Information

• Brand Name: MARA Ext.Lower Stop Ctr(10Pk)
• Primary DI: D8199014100
• Version / Model: 901410
• Company Name: SPECIALTY APPLIANCES, LLC
• Labeler DUNS: 106645484
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-26
• Public Version: 1
• Public Version Date: 2024-08-05
• Public Version Status: New
• Public Device Record Key: d91a5008-7f00-4f24-b03f-b46dc67425be

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ECN	Clamp, Wire, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63223	Orthodontic power arm	A dental device in the shape of a straight pin or hook designed to accept an elastic band, power chain, spring, or archwire (not included), which apply a force in addition to the main orthodontic archwire, for vertical alignment and/or horizontal positioning of the teeth; it may include a base that functions as an orthodontic lock/stop. The device is typically crimped, soldered, screwed on, or inserted in the slot of an orthodontic attachment (e.g., bracket, band), or on the surface of a tooth for orthodontic traction. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D8199014105	HIBCC		10	In Commercial Distribution
Primary	D8199014100	HIBCC