Concerto Detachable Coil System

GUDID 00847536045132

COIL PV-4-10-3D V05

Micro Therapeutics, Inc.

Non-neurovascular embolization coil
Primary Device ID00847536045132
NIH Device Record Keycb376729-492d-4e78-bcec-565ce87db2f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameConcerto Detachable Coil System
Version Model NumberPV-4-10-3D
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100847536045132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRDDevice, Vascular, for Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-13
Device Publish Date2022-06-04

On-Brand Devices [Concerto Detachable Coil System]

00847536044982COIL NV-9-30-HELIX V07
00847536044968COIL NV-7-30-HELIX V07
00847536044951COIL NV-6-20-HELIX V07
00847536044944COIL NV-5-20-HELIX V07
00847536044937COIL NV-5-15-HELIX V07
00847536044920COIL NV-4-10-HELIX V07
00847536044913COIL NV-4-8-HELIX V07
00847536044906COIL NV-3-8-HELIX V07
00847536044869COIL NV-2-4-HELIX V07
00763000307240COIL NV-10-20-HELIX V07
00763000307226COIL NV-8-20-HELIX V07
00763000307219COIL NV-7-20-HELIX V07
00763000307202COIL NV-6-12-HELIX V07
00763000307233COIL NV-9-20-HELIX V07
00763000307196COIL NV-5-10-HELIX V07
00847536044999COIL NV-10-30-HELIX V07
00847536044975COIL NV-8-30-HELIX V07
00847536044890COIL NV-3-4-HELIX V07
00847536044883COIL NV-2-8-HELIX V07
00847536044876COIL NV-2-6-HELIX V07
00847536045347COIL PV-18-40-3D V05
00847536045330COIL PV-16-40-3D V05
00847536045323COIL PV-14-40-3D V05
00847536045316COIL PV-12-40-3D V05
00847536045200COIL PV-10-30-3D V05
00847536045194COIL PV-9-30-3D V05
00847536045187COIL PV-8-30-3D V05
00847536045170COIL PV-7-30-3D V05
00847536045163COIL PV-6-20-3D V05
00847536045156COIL PV-5-15-3D V05
00847536045149COIL PV-4-12-3D V05
00847536045132COIL PV-4-10-3D V05
00847536045125COIL PV-3-8-3D V05
00847536045118COIL PV-3-6-3D V05
00847536045101COIL PV-3-4-3D V05
00847536045095COIL PV-2-6-3D V05
00847536045088COIL PV-2-4-3D V05
00847536045071COIL PV-2-2-3D V05
00847536045064COIL PV-20-50-HELIX V07
00847536045057COIL PV-18-40-HELIX V07
00847536045040COIL PV-16-40-HELIX V07
00847536045026COIL PV-14-30-HELIX V07
00847536045002COIL PV-12-30-HELIX V07
00763000307257COIL PV-4-8-3D V05
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.