IPS

Basic Information

• Brand Name: IPS
• Primary DI: 00888118144850
• Version / Model: 60-500-25-09-PP
• Company Name: KLS-Martin L.P.
• Labeler DUNS: 826499238
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-08
• Public Version: 3
• Public Version Date: 2024-11-08
• Public Version Status: Update
• Public Device Record Key: 682b0953-7d43-453a-b6ea-d12570d32ca5

Device Description

SPLINT, PALATAL, ALT, TI-6AL-4V

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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JEY	PLATE, BONE	Dental	872.4760	2
DZJ	DRIVER, WIRE, AND BONE DRILL, MANUAL	Dental	872.4120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67349	Fixed dental occlusal splint, custom-made	A rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, typically in the perioperative period after trauma or orthognathic surgery (surgical orthodontics). It is fixed to the teeth with ligature wires by a clinician and is intended to remain in place short-term (<=30 days) until sufficient bone healing has taken place. The device is manufactured to meet the needs of an individual patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888118144850	GS1

Customer Contacts

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