| Primary Device ID | 00613994505484 |
| NIH Device Record Key | 8f33cf1e-d9f7-4492-8576-6d38db1afccb |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6057-110 |
| Company DUNS | 006261481 |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Length | 110 Centimeter |
| Length | 110 Centimeter |
| Length | 110 Centimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Outer Diameter | 0.356 Millimeter |
| Length | 110 Centimeter |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994505484 [Primary] |
| DRB | STYLET, CATHETER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-02 |
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| 00643169525634 - Annuloplasty Handle | 2025-12-30 HANDLE 7686 ANNULOPLASTY 26L |
| 00643169525641 - Annuloplasty Handle | 2025-12-30 HANDLE 7686XL ANNULOPLASTY 26L |