Code Rings

Basic Information

• Brand Name: Code Rings
• Primary DI: D701CR112
• Version / Model: CR11
• Company Name: PULPDENT CORPORATION
• Labeler DUNS: 001006089
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-09-22
• Public Version: 1
• Public Version Date: 2021-09-30
• Public Version Status: New
• Public Device Record Key: 13f1061a-e5d1-439a-bb84-0950d5d9ac92

Device Description

Silicone, medical grade. Box of 100 – pink

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	872.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47825	Surgical instrument track identification tape	A non-sterile, colour-coded, band coated on one side with a pressure-sensitive adhesive intended to attach to a surgical instrument; it is typically wrapped around the handle or shaft to indicate instrument ownership (e.g., by doctor, hospital floor, department or ward) and identifies the instrument prior to and during a surgical procedure. This marking will facilitate that the correct instruments are returned to the correct owner particularly after being sterilized in the hospital sterilization department or other facility. It is typically made of plastic material and is available in a sheet with different size strips of tape or in continuous roll (a spool). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D701CR112	HIBCC
Unit of Use	D701CR111	HIBCC