Nobil

Basic Information

• Brand Name: Nobil
• Primary DI: 00842092127308
• Version / Model: 0102000
• Catalog Number: 0102000
• Company Name: Preat Corporation
• Labeler DUNS: 117776048
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-25
• Public Version: 4
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: 10612daf-ad9a-4d89-a61d-1aadd8706818
• Distribution End Date: 2023-01-12

Device Description

Nobil Grip

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, implant, dental, endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62200	Zinc oxide eugenol dental cement	A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842092127308	GS1
Package	00842092155660	GS1	Pack	3	Not in Commercial Distribution	2023-01-12