Inspire ICE

Basic Information

• Brand Name: Inspire ICE
• Primary DI: 00889989081008
• Version / Model: 443-3310
• Company Name: ORMCO CORPORATION
• Labeler DUNS: 154614119
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-12-14
• Public Version: 5
• Public Version Date: 2023-12-06
• Public Version Status: Update
• Public Device Record Key: dd214b7a-6784-444a-bdb0-f5d1378f3b5c
• Distribution End Date: 2023-12-04

Device Description

U3R INSPIRE ICE MCLAUGHLIN, BENNETT & TREVISI .018 0/8/0 HK

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: No
• Has Serial Number: No
• 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
NJM	Bracket, Ceramic, Orthodontic	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58937	Orthodontic bracket, ceramic	A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. 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	00889989081008	GS1
Unit of Use	10889989081005	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Angulation: 0
Device Size Text, specify			Torque: 0
Device Size Text, specify			Slot Size: .018