Freehand Ring

Basic Information

• Brand Name: Freehand Ring
• Primary DI: 00860000626903
• Version / Model: FR403
• Company Name: PURA DENTAL PRODUCTS LLC
• Labeler DUNS: 046937930
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-17
• Public Version: 1
• Public Version Date: 2020-12-25
• Public Version Status: New
• Public Device Record Key: 819de15d-c26d-45be-8d8b-e7cb967a2521

Device Description

Freehand Ring platform ring is an autoclavable ring worn on the finger during dental procedures which holds two types of disposable inserts. A foam insert used to remove debris from instrument tips during instrumentation or a well insert used to hold substances that are being applied to the oral cavity.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: No
• 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
EJB	Handle, Instrument, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65034	Wearable dental procedure holding ring	A plastic, ring-like device intended to be worn on the finger of a dental professional to accept and hold various dedicated accessories (e.g., instrument cleaning pads, instrument holders, dental substance receptacles) used during a dental procedure. This is a reusable device.	No	Active
65035	Wearable dental procedure holding ring cleaning pad	A rough, foam-like device intended for use with (inserted into) a wearable dental procedure holding ring (not included) to clean and remove debris from dental instruments during procedures. This is a single-use device.	No	Active
65036	Wearable dental procedure holding ring well	A shallow open receptacle intended for use with (inserted into) a wearable dental procedure holding ring (not included) to hold liquid, paste and gel-like dental substances or other small materials used during procedures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860000626903	GS1