ROEKO Guttapercha Points

Basic Information

• Brand Name: ROEKO Guttapercha Points
• Primary DI: E1653651351
• Version / Model: 365135
• Catalog Number: 365135
• Company Name: Coltène/Whaledent GmbH + Co. KG
• Labeler DUNS: 315494443
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-10-23
• Public Version: 1
• Public Version Date: 2023-10-31
• Public Version Status: New
• Public Device Record Key: df9e5d40-897c-4d05-a017-3b2205d291e3

Device Description

ROEKO Guttapercha Points Top color ISO 35

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
EKM	Gutta-Percha	Dental	872.3850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34791	Root canal obturating point	A metallic or polymeric based point or cone suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	E1653651350	HIBCC
Primary	E1653651351	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: keep away from sunlight
• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: – 77 Degrees Fahrenheit