ROEKO GuttaFlow®2 60013719

GUDID E165600137190

ROEKO GuttaFlow®2 Mixing tips

Coltène/Whaledent GmbH + Co. KG

Dental material mixing nozzle, non-sterile

• Primary Device ID: E165600137190
• NIH Device Record Key: 74642a78-fba5-4182-be53-cb65d76467bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROEKO GuttaFlow®2
• Version Model Number: 60013719
• Catalog Number: 60013719
• Company DUNS: 315494443
• Company Name: Coltène/Whaledent GmbH + Co. KG
• Device Count: 24
• 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: false
• 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
• Phone: +4973458050
• Email: info.de@coltene.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E165600137190 [Unit of Use]
HIBCC	E165600137192 [Primary]

FDA Product Code

• DZN: Instruments, Dental Hand

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: 2022-09-30
• Device Publish Date: 2022-09-22

On-Brand Devices [ROEKO GuttaFlow®2]

• E165600195290: SAMPLE
• E165600137450: REFILL PACK DUAL-BARREL SYRING
• E165600137060: REFILL PACK CAPSULES FAST
• E165600137040: REFILL PACK CAPSULES REGULAR
• E165600137020: The ROEKO GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips + St
• E165600137010: STANDARD SET
• E165600137190: ROEKO GuttaFlow®2 Mixing tips