Contour 3D™
GUDID 00613994845337
RING 690R28 CONTOUR 3D 26L
MEDTRONIC, INC.
Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring| Primary Device ID | 00613994845337 |
| NIH Device Record Key | 5608da94-6381-40fa-906a-6ed00ad43a65 |
| Commercial Distribution Discontinuation | 2018-10-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Contour 3D™ |
| Version Model Number | 690R28 |
| 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 | 28 Millimeter |
| Lumen/Inner Diameter | 28 Millimeter |
| Lumen/Inner Diameter | 28 Millimeter |
| Lumen/Inner Diameter | 28 Millimeter |
| Lumen/Inner Diameter | 28 Millimeter |
| Lumen/Inner Diameter | 28 Millimeter |
| Lumen/Inner Diameter | 28 Millimeter |
| Lumen/Inner Diameter | 28 Millimeter |
| Lumen/Inner Diameter | 28 Millimeter |
| Lumen/Inner Diameter | 28 Millimeter |
| Lumen/Inner Diameter | 28 Millimeter |
| Lumen/Inner Diameter | 28 Millimeter |
| Lumen/Inner Diameter | 28 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, 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 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, 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 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, 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 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, 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 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, 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 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, 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 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, 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 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, 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 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, 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 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, 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 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, 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 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, dry area to protect the product and minimize the potential for contamination. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994845337 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101212
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 | 4 |
| Public Version Date | 2018-12-19 |
| Device Publish Date | 2015-06-17 |
On-Brand Devices [Contour 3D™]
| 00613994845375 | RING 690R36 CONTOUR 3D 26L |
| 00613994845368 | RING 690R34 CONTOUR 3D 26L |
| 00613994845351 | RING 690R32 CONTOUR 3D 26L |
| 00613994845344 | RING 690R30 CONTOUR 3D 26L |
| 00613994845337 | RING 690R28 CONTOUR 3D 26L |
| 00613994845320 | RING 690R26 CONTOUR 3D 26L |
Trademark Results [Contour 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CONTOUR 3D 77782827 3941364 Live/Registered |
Medtronic, Inc. 2009-07-16 |
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