ROEKO Paper Points 344530

GUDID E1653445300

ROEKO Paper Points Top color ISO 30

Coltène/Whaledent GmbH + Co. KG

Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point

• Primary Device ID: E1653445300
• NIH Device Record Key: f34bf454-2413-4158-a2d0-76020a1fe48a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROEKO Paper Points
• Version Model Number: 344530
• Catalog Number: 344530
• Company DUNS: 315494443
• Company Name: Coltène/Whaledent GmbH + Co. KG
• Device Count: 200
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E1653445300 [Unit of Use]
HIBCC	E1653445301 [Primary]

FDA Product Code

• EKN: Point, Paper, Endodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-31
• Device Publish Date: 2023-10-23

On-Brand Devices [ROEKO Paper Points]

• E1653445400: ROEKO Paper Points Top color ISO 40
• E1653445350: ROEKO Paper Points Top color ISO 35
• E1653445300: ROEKO Paper Points Top color ISO 30
• E1653445200: ROEKO Paper Points Top color ISO 20