ROEKO GuttaFlow®2 60013706

GUDID E165600137060

Coltène/Whaledent GmbH + Co. KG

Endodontic filling/sealing material
Primary Device IDE165600137060
NIH Device Record Key5290e8ab-a283-438c-a239-7cc41c73f587
Commercial Distribution StatusIn Commercial Distribution
Brand NameROEKO GuttaFlow®2
Version Model NumberREFILL PACK CAPSULES FAST
Catalog Number60013706
Company DUNS315494443
Company NameColtène/Whaledent GmbH + Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4973458050
Emailinfo.de@coltene.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE165600137060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKMGutta-Percha

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-23

On-Brand Devices [ROEKO GuttaFlow®2]

E165600195290SAMPLE
E165600137450REFILL PACK DUAL-BARREL SYRING
E165600137060REFILL PACK CAPSULES FAST
E165600137040REFILL PACK CAPSULES REGULAR
E165600137020The ROEKO GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips + St
E165600137010STANDARD SET
E165600137190ROEKO GuttaFlow®2 Mixing tips

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