Micra™ VR2
GUDID 00763000078683
TPS MC2VR01 MICRA VR2 US
MEDTRONIC, INC.
Intracardiac pacemaker| Primary Device ID | 00763000078683 |
| NIH Device Record Key | d57c9515-1c08-45a7-b2e1-e5e4829415d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micra™ VR2 |
| Version Model Number | MC2VR01 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
Operating and Storage Conditions
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000078683 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P150033
FDA Product Code
| PNJ | Leadless pacemaker |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-15 |
| Device Publish Date | 2023-05-05 |
Devices Manufactured by MEDTRONIC, INC.
| 20763000982946 - NA | 2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD |
| 00763000984007 - NA | 2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG |
| 00763000984021 - NA | 2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE |
| 00763000984151 - NA | 2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT |
| 00763000984168 - NA | 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS |
| 00763000984175 - NA | 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK |
| 00763000180010 - Sprint Quattro Secure S™ | 2024-11-12 LEAD 693552 SPRINT US RCMCRD |
| 00763000180027 - Sprint Quattro Secure S™ | 2024-11-12 LEAD 693575 SPRINT US RCMCRD |
Trademark Results [Micra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MICRA 86794383 not registered Live/Pending |
Nissan Jidosha Kabushiki Kaisha 2015-10-21 |
 MICRA 85715767 4568896 Live/Registered |
Medtronic, Inc. 2012-08-29 |
 MICRA 85646130 4584996 Live/Registered |
Medtronic, Inc. 2012-06-07 |
 MICRA 85373179 not registered Dead/Abandoned |
Shiela Nail Products, Inc. 2011-07-16 |
MICRA 85373179 not registered Dead/Abandoned |
J-mar International 2011-07-16 |
 MICRA 79048392 3492995 Dead/Cancelled |
CONTROLLI S.P.A. 2007-12-20 |
 MICRA 78363412 not registered Dead/Abandoned |
Microeconomic Consulting & Research Associates, Inc. 2004-02-05 |
 MICRA 77577332 3688412 Dead/Cancelled |
Nissan Jidosha Kabushiki Kaisha 2008-09-24 |
 MICRA 76438044 2715711 Dead/Cancelled |
KIDDE PRODUCTS LIMITED 2002-08-05 |
 MICRA 76303416 2741079 Dead/Cancelled |
Montegrappa 1912 S.p.A. 2001-08-22 |
 MICRA 75871337 2622792 Dead/Cancelled |
NISSAN JIDOSHA KABUSHIKI KAISHA 1999-12-14 |
 MICRA 75639758 not registered Dead/Abandoned |
NISSAN JIDOSHA KABUSHIKI KAISHA 1999-02-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.