HyFlex Guttapercha Points 60036504

GUDID 04260614073401

HyFlex EDM OGSF Guttapercha Points 0.04 # 30

Coltène/Whaledent GmbH + Co. KG

Root canal obturating point

• Primary Device ID: 04260614073401
• NIH Device Record Key: 8da5c157-aab8-4158-bf10-fca9c035e5d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyFlex Guttapercha Points
• Version Model Number: 60036504
• Catalog Number: 60036504
• Company DUNS: 315494443
• Company Name: Coltène/Whaledent GmbH + Co. KG
• Device Count: 60
• 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: false
• 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: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 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 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260614073401 [Unit of Use]
GS1	14260614073408 [Primary]

FDA Product Code

• EKM: Gutta-Percha

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-02
• Device Publish Date: 2024-03-25

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