ROEKO Guttapercha Points 364015

GUDID E1653640150

ROEKO Guttapercha Points conventional # M

Coltène/Whaledent GmbH + Co. KG

Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point

Primary Device ID	E1653640150
NIH Device Record Key	ed008c7c-44ed-4ae5-bf12-1f73125e5892
Commercial Distribution Status	In Commercial Distribution
Brand Name	ROEKO Guttapercha Points
Version Model Number	364015
Catalog Number	364015
Company DUNS	315494443
Company Name	Coltène/Whaledent GmbH + Co. KG
Device Count	100
DM Exempt	false
Pre-market Exempt	true
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	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@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 away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E1653640150 [Unit of Use]
HIBCC	E1653640151 [Primary]

FDA Product Code

EKM	Gutta-Percha

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	2024-05-21
Device Publish Date	2024-05-13

On-Brand Devices [ROEKO Guttapercha Points]

E1653651960	ROEKO Guttapercha Points Top color ISO 15-40
E1653651450	ROEKO Guttapercha Points Top color ISO 45
E1653651400	ROEKO Guttapercha Points Top color ISO 40
E1653651350	ROEKO Guttapercha Points Top color ISO 35
E1653651300	ROEKO Guttapercha Points Top color ISO 30
E1653651250	ROEKO Guttapercha Points Top color ISO 25
E1653651150	ROEKO Guttapercha Points Top color ISO 15
E1653640130	ROEKO Guttapercha Points conventional # F
E1653640100	ROEKO Guttapercha Points conventional # XF
E1653640150	ROEKO Guttapercha Points conventional # M