Duran AnCore®
GUDID 00613994759061
BAND 620BG25 DURAN ANCORE 10L MEXICO
MEDTRONIC, INC.
Mitral/tricuspid annuloplasty ring| Primary Device ID | 00613994759061 |
| NIH Device Record Key | 822ff874-3289-4ab2-bf41-1550a41a3128 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Duran AnCore® |
| Version Model Number | 620BG25 |
| 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 | 25 Millimeter |
| Lumen/Inner Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 25 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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 | 00613994759061 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K032810
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 | 2019-08-12 |
| Device Publish Date | 2015-06-17 |
On-Brand Devices [Duran AnCore®]
| 00613994759160 | BAND 620BG35 DURAN ANCORE 10L MEXICO |
| 00613994759146 | BAND 620BG33 DURAN ANCORE 10L MEXICO |
| 00613994759122 | BAND 620BG31 DURAN ANCORE 10L MEXICO |
| 00613994759108 | BAND 620BG29 DURAN ANCORE 10L MEXICO |
| 00613994759085 | BAND 620BG27 DURAN ANCORE 10L MEXICO |
| 00613994759061 | BAND 620BG25 DURAN ANCORE 10L MEXICO |
| 00613994759047 | BAND 620BG23 DURAN ANCORE 10L MEXICO |
| 00613994759023 | RING 620RG35 DURAN ANCORE 10L MEXICO |
| 00613994759009 | RING 620RG33 DURAN ANCORE 10L MEXICO |
| 00613994758989 | RING 620RG31 DURAN ANCORE 10L MEXICO |
| 00613994758965 | RING 620RG29 DURAN ANCORE 10L MEXICO |
| 00613994758941 | RING 620RG27 DURAN ANCORE 10L MEXICO |
| 00613994758927 | RING 620RG25 DURAN ANCORE 10L MEXICO |
| 00613994758903 | RING 620RG23 DURAN ANCORE 10L MEXICO |
| 00613994749796 | BAND 620BG23 DURAN ANCORE 10L INSERT |
| 00613994749789 | BAND 620BG25 DURAN ANCORE 10L INSERT |
| 00613994749772 | BAND 620BG27 DURAN ANCORE 10L INSERT |
| 00613994749765 | BAND 620BG29 DURAN ANCORE 10L INSERT |
| 00613994749758 | BAND 620BG31 DURAN ANCORE 10L INSERT |
| 00613994749741 | BAND 620BG33 DURAN ANCORE 10L INSERT |
| 00613994749734 | BAND 620BG35 DURAN ANCORE 10L INSERT |
| 00613994749727 | RING 620RG23 DURAN ANCORE 10L INSERT |
| 00613994749710 | RING 620RG25 DURAN ANCORE 10L INSERT |
| 00613994749703 | RING 620RG27 DURAN ANCORE 10L INSERT |
| 00613994749697 | RING 620RG29 DURAN ANCORE 10L INSERT |
| 00613994749680 | RING 620RG31DURAN ANCORE 10L INSERT |
| 00613994749673 | RING 620RG33 DURAN ANCORE 10L INSERT |
| 00613994749666 | RING 620RG35 DURAN ANCORE 10L INSERT |
| 00613994527066 | BAND 620BG27 ANLO DURAN ANCORE CHORD 10L |
| 00613994527059 | BAND 620BG29 DURAN ANCORE CHORD 10L |
| 00613994527028 | BAND 620BG35 ANLO DURAN ANCORE CHORD 10L |
| 00613994526984 | RING 620RG29 ANLO DURAN ANCORE CHORD 10L |
| 00613994526977 | RING 620RG31 ANLO DURAN ANCORE CHORD 10L |
| 00613994526960 | RING 620RG33 ANLO DURAN ANCORE CHORD 10L |
| 00721902859823 | RING 620RG35 ANLO DURAN ANCORE CHORD 10L |
| 00721902859816 | RING 620RG33 ANLO DURAN ANCORE CHORD 10L |
| 00721902859809 | RING 620RG31 ANLO DURAN ANCORE CHORD 10L |
| 00721902859793 | RING 620RG29 ANLO DURAN ANCORE CHORD 10L |
| 00721902859786 | RING 620RG27 ANLO DURAN ANCORE CHORD 10L |
| 00721902859762 | RING 620RG25 ANLO DURAN ANCORE CHORD 10L |
| 00721902859755 | RING 620RG23 ANLO DURAN ANCORE CHORD 10L |
Trademark Results [Duran AnCore]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURAN ANCORE 78131413 2849287 Live/Registered |
MEDTRONIC INC. 2002-05-28 |
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