ROEKO Retracto 511001

GUDID E1655110010

ROEKO Retracto Braided non-impregnated size 1 (fine)

Coltène/Whaledent GmbH + Co. KG

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• Primary Device ID: E1655110010
• NIH Device Record Key: 6a6e39c4-4e8a-4440-9cb0-72a2a04e2cbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROEKO Retracto
• Version Model Number: 511001
• Catalog Number: 511001
• Company DUNS: 315494443
• Company Name: Coltène/Whaledent GmbH + Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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
• 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 dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E1655110010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041023

FDA Product Code

• MVL: Cord, Retraction

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 Retracto]

• E1655230020: ROEKO Retracto Twisted non-impregnated size 2 (medium)
• E1655230010: ROEKO Retracto Twisted non-impregnated size 1 (fine)
• E1655230000: ROEKO Retracto Twisted non-impregnated size 0 (x-fine)
• E1655110030: ROEKO Retracto Braided non-impregnated size 3 (thick)
• E1655110020: ROEKO Retracto Braided non-impregnated size 2 (medium)
• E1655110010: ROEKO Retracto Braided non-impregnated size 1 (fine)
• E1655110000: ROEKO Retracto Braided non-impregnated size 0 (x-fine)