Primary Device ID | 00763000865405 |
NIH Device Record Key | d57863ec-dafe-4996-8c08-9390cd9c789e |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | RS5220A |
Company DUNS | 796986144 |
Company Name | MEDTRONIC, INC. |
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 | true |
Device Combination Product | false |
Single Use | false |
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 |
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 | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000865405 [Primary] |
QON | Implanted electrical device intended for treatment of fecal incontinence |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-14 |
Device Publish Date | 2024-05-06 |
00199150042005 - NA | 2025-08-29 CUSTOM PACK BB7E29R28 EVL 3/8 |
00199150042012 - NA | 2025-08-29 CUSTOM PACK BB11L88R8 EVL SUPPRT SM |
00199150042029 - NA | 2025-08-29 CUSTOM PACK BB12P62R3 EVL 1/4 |
00199150042043 - NA | 2025-08-29 CUSTOM PACK BB9E98R16 EVL WCH PED |
00199150042067 - NA | 2025-08-29 CUSTOM PACK BB7E31R31 EVL 1 EVT 1/4 |
00199150042739 - NA | 2025-08-29 CUSTOM PACK BB7V67R13 HLO PRESBY |
00199150042746 - NA | 2025-08-29 CUSTOM PACK BB0C00R32 EVL 3/8SUPPT |
00763000658960 - Profile 3D™ | 2025-08-29 HANDLE 7686L ANNULOPLASTY2 MDR |