ELCA™ 120-008

GUDID M204120008AA0

ELCA™ Coronary Laser Atherectomy Catheter

Spectranetics Corporation

Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary Atherectomy laser system beam guide-catheter, coronary
Primary Device IDM204120008AA0
NIH Device Record Key1bbca2cb-4705-44e9-812b-4b9be75bfb40
Commercial Distribution StatusIn Commercial Distribution
Brand NameELCA™
Version Model Number120-008AA
Catalog Number120-008
Company DUNS151047370
Company NameSpectranetics Corporation
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

Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com

Device Dimensions

Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100813132020071 [Primary]
HIBCCM204120008AA0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPCDevice, Angioplasty, Laser, Coronary

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


[M204120008AA0]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-02-06

On-Brand Devices [ELCA™]

00813132025489ELCA™ Coronary Laser Atherectomy Catheter
00813132025472ELCA™ Coronary Laser Atherectomy Catheter
00813132025465ELCA™ Coronary Laser Atherectomy Catheter
00813132025458ELCA™ Coronary Laser Atherectomy Catheter
00813132025441ELCA™ Coronary Laser Atherectomy Catheter
00813132025434ELCA™ Coronary Laser Atherectomy Catheter
00813132025427ELCA™ Coronary Laser Atherectomy Catheter
00813132025410ELCA™ Coronary Laser Atherectomy Catheter
00813132025403ELCA™ Coronary Laser Atherectomy Catheter
M204120009AA0ELCA™ Coronary Laser Atherectomy Catheter
M204120008AA0ELCA™ Coronary Laser Atherectomy Catheter
M204117205AA0ELCA™ Coronary Laser Atherectomy Catheter
M204117016AA0ELCA™ Coronary Laser Atherectomy Catheter
M204114009AA0ELCA™ Coronary Laser Atherectomy Catheter
M204110004AA0ELCA™ Coronary Laser Atherectomy Catheter
M204110003AA0ELCA™ Coronary Laser Atherectomy Catheter
M204110002AA0ELCA™ Coronary Laser Atherectomy Catheter
M204110001AA0ELCA™ Coronary Laser Atherectomy Catheter
M2041200090ELCA™ Coronary Laser Atherectomy Catheter
M2041200080ELCA™ Coronary Laser Atherectomy Catheter
M2041172050ELCA™ Coronary Laser Atherectomy Catheter
M2041170160ELCA™ Coronary Laser Atherectomy Catheter
M2041140090ELCA™ Coronary Laser Atherectomy Catheter
M2041100040ELCA™ Coronary Laser Atherectomy Catheter
M2041100030ELCA™ Coronary Laser Atherectomy Catheter
M2041100020ELCA™ Coronary Laser Atherectomy Catheter
M2041100010ELCA™ Coronary Laser Atherectomy Catheter

Trademark Results [ELCA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ELCA
ELCA
79312200 not registered Live/Pending
ELCA S.R.L.
2021-02-26
ELCA
ELCA
76559839 2906015 Live/Registered
Evangelical Lutheran Church in America
2003-10-29
ELCA
ELCA
74247370 1823660 Live/Registered
SPECTRANETICS CORPORATION, THE
1992-02-13
ELCA
ELCA
72164677 0770656 Dead/Expired
ELECTROCHIMICA CORPORATION
1963-03-04

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