FitStrip™

Basic Information

• Brand Name: FitStrip™
• Primary DI: 00810038094038
• Version / Model: FPSK04
• Catalog Number: FPSK04
• Company Name: GARRISON DENTAL SOLUTIONS, L.L.C.
• Labeler DUNS: 057647005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-24
• Public Version: 1
• Public Version Date: 2020-05-04
• Public Version Status: New
• Public Device Record Key: f07c8d4e-70e8-43e2-9b35-1785e071aa2f

Device Description

Universal Kit: (1) IPR Gauge, (4) Single-Sided Strips - 1 of Each 0.08mm, 0.10mm, 0.13mm, 0.18mm, (6) Double-Sided Strips - 1 of Each 0.11mm, 0.15mm, 0.21mm, 0.30mm, 0.40mm, 0.50mm, (2) Handles

Device Characteristics

• Single Use: No
• 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: 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
DZP	Instrument, Diamond, Dental	Dental	872.4535	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35702	Dental abrasive strip, single-use	A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810038094038	GS1

Customer Contacts

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