ROEKO Stay-put 521003

GUDID E1655210030

ROEKO Stay-put non-impregnated size 3 (thick)

Coltène/Whaledent GmbH + Co. KG

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• Primary Device ID: E1655210030
• NIH Device Record Key: f78a7bfb-8a0e-4ee8-a240-1e308ec1a73e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROEKO Stay-put
• Version Model Number: 521003
• Catalog Number: 521003
• 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	E1655210030 [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 Stay-put]

• E1655210030: ROEKO Stay-put non-impregnated size 3 (thick)
• E1655210020: ROEKO Stay-put non-impregnated size 2 (medium)
• E1655210010: ROEKO Stay-put non-impregnated size 1 (fine)
• E1655210000: ROEKO Stay-put non-impregnated size 0 (x-fine)