ROEKO Retracto 523001

GUDID E1655230010

ROEKO Retracto Twisted non-impregnated size 1 (fine)

Coltène/Whaledent GmbH + Co. KG

Gingival retraction cord, non-medicated
Primary Device IDE1655230010
NIH Device Record Key70f4a8be-b595-4c7e-a521-907edc545543
Commercial Distribution StatusIn Commercial Distribution
Brand NameROEKO Retracto
Version Model Number523001
Catalog Number523001
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
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE1655230010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVLCord, Retraction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-30
Device Publish Date2022-09-22

On-Brand Devices [ROEKO Retracto]

E1655230020ROEKO Retracto Twisted non-impregnated size 2 (medium)
E1655230010ROEKO Retracto Twisted non-impregnated size 1 (fine)
E1655230000ROEKO Retracto Twisted non-impregnated size 0 (x-fine)
E1655110030ROEKO Retracto Braided non-impregnated size 3 (thick)
E1655110020ROEKO Retracto Braided non-impregnated size 2 (medium)
E1655110010ROEKO Retracto Braided non-impregnated size 1 (fine)
E1655110000ROEKO Retracto Braided non-impregnated size 0 (x-fine)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.