PROFILE 3D™
GUDID 00613994749437
RING 680R36 PROFILE 3D 26L INSERT
MEDTRONIC, INC.
Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring| Primary Device ID | 00613994749437 |
| NIH Device Record Key | 2b6c662f-b1fc-4c9b-99b7-b231844100e9 |
| Commercial Distribution Discontinuation | 2017-07-17 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PROFILE 3D™ |
| Version Model Number | 680R36 |
| 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 | false |
| 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 |
Device Dimensions
| Lumen/Inner Diameter | 36 Millimeter |
| Lumen/Inner Diameter | 36 Millimeter |
| Lumen/Inner Diameter | 36 Millimeter |
| Lumen/Inner Diameter | 36 Millimeter |
| Lumen/Inner Diameter | 36 Millimeter |
| Lumen/Inner Diameter | 36 Millimeter |
| Lumen/Inner Diameter | 36 Millimeter |
| Lumen/Inner Diameter | 36 Millimeter |
| Lumen/Inner Diameter | 36 Millimeter |
| Lumen/Inner Diameter | 36 Millimeter |
| Lumen/Inner Diameter | 36 Millimeter |
| Lumen/Inner Diameter | 36 Millimeter |
| Lumen/Inner Diameter | 36 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994749437 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K073324
FDA Product Code
| KRH | RING, ANNULOPLASTY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-06-18 |
On-Brand Devices [PROFILE 3D™]
| 00613994749437 | RING 680R36 PROFILE 3D 26L INSERT |
| 00613994749420 | RING 680R34 PROFILE 3D 26L INSERT |
| 00613994749413 | RING 680R32 PROFILE 3D 26L INSERT |
| 00613994749406 | RING 680R30 PROFILE 3D 26L INSERT |
| 00613994749390 | RING 680R28 PROFILE 3D 26L INSERT |
| 00613994749383 | RING 680R26 PROFILE 3D 26L INSERT |
| 00613994749376 | RING 680R24 PROFILE 3D 26L INSERT |
| 00613994410344 | RING 680R26 PROFILE 3D 26L |
| 00613994410337 | RING 680R32 PROFILE 3D 26L |
| 00613994410313 | RING 680R28 PROFILE 3D 26L |
| 00613994410306 | RING 680R30 PROFILE 3D 26L |
| 00613994410283 | RING 680R38 PROFILE 3D 26L |
| 00763000318505 | SIZER SET 7680S PROFILE 3D 26L CE |
Trademark Results [PROFILE 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROFILE 3D 77107095 3473054 Live/Registered |
Medtronic, Inc. 2007-02-14 |
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