Selectra 443628

GUDID 04035479162092

BIOTRONIK SE & Co. KG

Vascular guide-catheter, single-use

Primary Device ID	04035479162092
NIH Device Record Key	dfeefc29-ac32-45ac-a517-0a052d65ded7
Commercial Distribution Status	In Commercial Distribution
Brand Name	Selectra
Version Model Number	3D-65-32
Catalog Number	443628
Company DUNS	315620229
Company Name	BIOTRONIK SE & 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	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com
Phone	+1(888)345-0374
Email	jon.brumbaugh@biotronik.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479162092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K193474

FDA Product Code

DQY	Catheter, percutaneous

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2021-12-22
Device Publish Date	2020-11-12

On-Brand Devices [Selectra]

04035479128746	IC-90-69
04035479128739	IC-90-59
04035479128722	IC-50-69
04035479128715	IC-50-59
04035479124564	Slitter
04035479121631	Straight-55
04035479116811	Straight-45
04035479116804	Right-55
04035479116798	Right-45
04035479116781	MPH-55
04035479116774	MPH-45
04035479116767	MPEP-55
04035479116750	MPEP-45
04035479116743	Hook-55
04035479116736	Hook-45
04035479116729	Extended Hook-55
04035479116712	Extended Hook-45
04035479116682	BIO2-55
04035479116675	BIO2-45
04035479116668	Amplatz 6.0-55
04035479116651	Amplatz 6.0-45
04035479116859	IC-90-75
04035479116842	IC-90-65
04035479116835	IC-50-75
04035479116828	IC-50-65
04035479176242	3D-40-42
04035479176235	3D-55-42
04035479176228	3D-65-42
07640130455412	3D-65-42
07640130455405	3D-55-42
07640130455399	3D-40-42
04035479162108	3D-65-39
04035479162092	3D-65-32
04035479162085	3D-55-39
04035479162078	3D-55-32
04035479162061	3D-40-39
04035479162054	3D-40-32
04035479116644	Accessory Kit

Trademark Results [Selectra]

Mark Image Registration \| Serial	Company Trademark Application Date
SELECTRA 86850166 5408010 Live/Registered	Applied Materials, Inc. 2015-12-15
SELECTRA 85293872 4218775 Live/Registered	Biotronik SE & Co. KG 2011-04-13
SELECTRA 79052761 not registered Dead/Abandoned	Selectra AG 2008-01-29
SELECTRA 78662220 not registered Dead/Abandoned	Ionalytics Corporation 2005-06-30
SELECTRA 78527567 not registered Dead/Abandoned	CABOT SAFETY INTERMEDIATE CORPORATION 2004-12-06
SELECTRA 78247664 2874608 Dead/Cancelled	ILLINOIS TOOL WORKS INC. 2003-05-09
SELECTRA 78207065 2786673 Dead/Cancelled	VITAL SCIENTIFIC, N.V. 2003-01-24
SELECTRA 76530126 not registered Dead/Abandoned	lonalytics Corporation 2003-07-07
SELECTRA 76189826 2692132 Dead/Cancelled	BASF CATALYSTS LLC 2001-01-05
SELECTRA 75722469 2611153 Dead/Cancelled	SIDEL S.A. 1999-06-07
SELECTRA 75694153 not registered Dead/Abandoned	Capital One Financial Corporation 1999-04-29
SELECTRA 75597349 not registered Dead/Abandoned	NOVITRON INTERNATIONAL, INC. 1998-11-23