ConcertoTM

GUDID 00847536017047

PV-14-40-HELIX CONCERTO PGLA COIL

Micro Therapeutics, Inc.

Non-neurovascular embolization coil
Primary Device ID00847536017047
NIH Device Record Key199bbd9f-b9fc-40ac-a811-70d13c458e09
Commercial Distribution StatusIn Commercial Distribution
Brand NameConcertoTM
Version Model NumberPV-14-40-HELIX
Company DUNS826110710
Company NameMicro Therapeutics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847536017047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRDDevice, Vascular, for Promoting Embolization

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00847536017047]

Ethylene Oxide

[00847536017047]

Ethylene Oxide

[00847536017047]

Ethylene Oxide

[00847536017047]

Ethylene Oxide

[00847536017047]

Ethylene Oxide

[00847536017047]

Ethylene Oxide

[00847536017047]

Ethylene Oxide

[00847536017047]

Ethylene Oxide

[00847536017047]

Ethylene Oxide

[00847536017047]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-17
Device Publish Date2015-09-07

On-Brand Devices [ConcertoTM]

00847536026520COIL PV-18-40-3D CONCERTO 3D V01
00847536026513COIL PV-16-40-3D CONCERTO 3D V01
00847536026506COIL PV-14-40-3D CONCERTO 3D V01
00847536026490COIL PV-12-40-3D CONCERTO 3D V01
00847536026483COIL PV-10-30-3D CONCERTO 3D V01
00847536026476COIL PV-10-20-3D CONCERTO 3D V01
00847536026469COIL PV-9-30-3D CONCERTO 3D V01
00847536026452COIL PV-9-20-3D CONCERTO 3D V01
00847536026445COIL PV-8-30-3D CONCERTO 3D V01
00847536026438COIL PV-8-20-3D CONCERTO 3D V01
00847536026421COIL PV-7-30-3D CONCERTO 3D V01
00847536026414COIL PV-7-20-3D CONCERTO 3D V01
00847536026407COIL PV-6-20-3D CONCERTO 3D V01
00847536026391COIL PV-6-15-3D CONCERTO 3D V01
00847536026384COIL PV-5-15-3D CONCERTO 3D V01
00847536026377COIL PV-5-10-3D CONCERTO 3D V01
00847536026360COIL PV-4-12-3D CONCERTO 3D V01
00847536026353COIL PV-4-10-3D CONCERTO 3D V01
00847536026346COIL PV-4-8-3D CONCERTO 3D V01
00847536026339COIL PV-3-8-3D V01 CONCERTO 3D
00847536026322COIL PV-3-6-3D V01 CONCERTO 3D
00847536026315COIL PV-3-4-3D V01 CONCERTO 3D
00847536026308COIL PV-2-6-3D V01 CONCERTO 3D
00847536026292COIL PV-2-4-3D V01 CONCERTO 3D
00847536026285COIL PV-2-2-3D V01 CONCERTO 3D
00847536017146CONCERTO HELIX 20MM X 50CM PGLA COIL
00847536017122CONCERTO HELIX 20MM X 50CM PGLA COIL
00847536017108CONCERTO HELIX 18MM X 40CM PGLA COIL
00847536017085CONCERTO HELIX 18MM X 40CM PGLA COIL
00847536017078CONCERTO HELIX 16MM X 40CM PGLA COIL
00847536017054CONCERTO HELIX 16MM X 40CM PGLA COIL
00847536017047PV-14-40-HELIX CONCERTO PGLA COIL
00847536017023PV-14-40-HELIX CONCERTO PGLA COIL
00847536017016CONCERTO HELIX 14MM X 30CM PGLA COIL
00847536016996CONCERTO HELIX 14MM X 30CM PGLA COIL
00847536016972PV-12-40-HELIX CONCERTO PGLA COIL
00847536016958PV-12-40-HELIX CONCERTO PGLA COIL
00847536016941CONCERTO HELIX 12MM X 30CM PGLA COIL
00847536016927CONCERTO HELIX 12MM X 30CM PGLA COIL
00847536013766CONCERTO HELIX 9MM X 30CM NYLON COIL
00847536013742CONCERTO HELIX 9MM X 30CM NYLON COIL
00847536013735NV-9-20-HELIX CONCERTO HELIX 9MMX20CM
00847536013711NV-9-20-HELIX CONCERTO HELIX 9MMX20CM
00847536013704NV-8-30-HELIX CONCERTO HELIX 8MMX30CM
00847536013681NV-8-30-HELIX CONCERTO HELIX 8MMX30CM
00847536013674CONCERTO HELIX 8MM X 20CM NYLON COIL
00847536013650NV-8-20-HELIX CONCERTO HELIX 8MMX20CM
00847536013643NYLON COIL NV-7-30-HELIX 7MM X 30CM
00847536013629NV-7-30-HELIX CONCERTO HELIX 7MMX30CM
00847536013612NV-7-20-HELIX CONCERTO HELIX 7MMX20CM
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.