Duran AnCore™
GUDID 00643169793408
RING 620RG31 DURAN ANCORE ANNULO 29L
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 Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery| Primary Device ID | 00643169793408 |
| NIH Device Record Key | 609b06b7-46c8-42e5-9f6f-0154b0f1865e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Duran AnCore™ |
| Version Model Number | 620RG31 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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
Device Dimensions
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 Millimeter |
| Lumen/Inner Diameter | 31 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 *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 away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| 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, and dry area to protect the product and minimize the potential for contamination. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169793408 [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 | 2 |
| Public Version Date | 2019-08-12 |
| Device Publish Date | 2018-03-08 |
On-Brand Devices [Duran AnCore™]
| 00643169793491 | BAND 620BG35 DURAN ANCORE ANNULO 29L |
| 00643169793484 | BAND 620BG33 DURAN ANCORE ANNULO 29L |
| 00643169793477 | BAND 620BG31 DURAN ANCORE ANNULO 29L |
| 00643169793460 | BAND 620BG29 DURAN ANCORE ANNULO 29L |
| 00643169793453 | BAND 620BG27 DURAN ANCORE ANNULO 29L |
| 00643169793446 | BAND 620BG25 DURAN ANCORE ANNULO 29L |
| 00643169793439 | BAND 620BG23 DURAN ANCORE ANNULO 29L |
| 00643169793422 | RING 620RG35 DURAN ANCORE ANNULO 29L |
| 00643169793415 | RING 620RG33 DURAN ANCORE ANNULO 29L |
| 00643169793408 | RING 620RG31 DURAN ANCORE ANNULO 29L |
| 00643169793392 | RING 620RG29 DURAN ANCORE ANNULO 29L |
| 00643169793385 | RING 620RG27 DURAN ANCORE ANNULO 29L |
| 00643169793378 | RING 620RG25 DURAN ANCORE ANNULO 29L |
| 00643169793361 | RING 620RG23 DURAN ANCORE ANNULO 29L |
Trademark Results [Duran AnCore]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURAN ANCORE 78131413 2849287 Live/Registered |
MEDTRONIC INC. 2002-05-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.