ROEKO Stay-put 521001

GUDID E1655210010

ROEKO Stay-put non-impregnated size 1 (fine)

Coltène/Whaledent GmbH + Co. KG

Gingival retraction cord, non-medicated
Primary Device IDE1655210010
NIH Device Record Keydefeeca4-15dd-47e8-965e-cbd56b920d3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameROEKO Stay-put
Version Model Number521001
Catalog Number521001
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
HIBCCE1655210010 [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 Stay-put]

E1655210030ROEKO Stay-put non-impregnated size 3 (thick)
E1655210020ROEKO Stay-put non-impregnated size 2 (medium)
E1655210010ROEKO Stay-put non-impregnated size 1 (fine)
E1655210000ROEKO Stay-put non-impregnated size 0 (x-fine)

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