SimuPlus™
GUDID 00763000271015
BAND 7700FB32 SIMUPLUS FLEX 32MM US
MEDTRONIC, INC.
Mitral/tricuspid annuloplasty ring| Primary Device ID | 00763000271015 |
| NIH Device Record Key | 907c676a-46f6-4bfe-8e41-26835bde65b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SimuPlus™ |
| Version Model Number | 7700FB32 |
| 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 | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 Millimeter |
| Lumen/Inner Diameter | 32 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, 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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 | 00763000271015 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201449
FDA Product Code
| KRH | RING, ANNULOPLASTY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-07 |
| Device Publish Date | 2020-07-30 |
On-Brand Devices [SimuPlus™]
| 00763000271565 | ACCY 7700FS SIMUPLUS R/B SIZERS SIL |
| 00763000271558 | ACCY 7700PS SIMUPLUS R/B SIZERS PS |
| 00763000271152 | RING 7700FR42 SIMUPLUS FLEX 42MM US |
| 00763000271145 | RING 7700FR40 SIMUPLUS FLEX 40MM US |
| 00763000271138 | RING 7700FR38 SIMUPLUS FLEX 38MM US |
| 00763000271121 | RING 7700FR36 SIMUPLUS FLEX 36MM US |
| 00763000271114 | RING 7700FR34 SIMUPLUS FLEX 34MM US |
| 00763000271107 | RING 7700FR32 SIMUPLUS FLEX 32MM US |
| 00763000271091 | RING 7700FR30 SIMUPLUS FLEX 30MM US |
| 00763000271084 | RING 7700FR28 SIMUPLUS FLEX 28MM US |
| 00763000271077 | RING 7700FR26 SIMUPLUS FLEX 26MM US |
| 00763000271060 | BAND 7700FB42 SIMUPLUS FLEX 42MM US |
| 00763000271053 | BAND 7700FB40 SIMUPLUS FLEX 40MM US |
| 00763000271046 | BAND 7700FB38 SIMUPLUS FLEX 38MM US |
| 00763000271039 | BAND 7700FB36 SIMUPLUS FLEX 36MM US |
| 00763000271022 | BAND 7700FB34 SIMUPLUS FLEX 34MM US |
| 00763000271015 | BAND 7700FB32 SIMUPLUS FLEX 32MM US |
| 00763000271008 | BAND 7700FB30 SIMUPLUS FLEX 30MM US |
| 00763000270995 | BAND 7700FB28 SIMUPLUS FLEX 28MM US |
| 00763000270988 | BAND 7700FB26 SIMUPLUS FLEX 26MM US |
| 00763000271459 | Ring 7700FR42 SimuPlus Flex 42mm GLB |
| 00763000271442 | Ring 7700FR40 SimuPlus Flex 40mm GLB |
| 00763000271435 | Ring 7700FR38 SimuPlus Flex 38mm GLB |
| 00763000271428 | Ring 7700FR36 SimuPlus Flex 36mm GLB |
| 00763000271411 | Ring 7700FR34 SimuPlus Flex 34mm GLB |
| 00763000271404 | Ring 7700FR32 SimuPlus Flex 32mm GLB |
| 00763000271398 | Ring 7700FR30 SimuPlus Flex 30mm GLB |
| 00763000271381 | Ring 7700FR28 SimuPlus Flex 28mm GLB |
| 00763000271374 | Ring 7700FR26 SimuPlus Flex 26mm GLB |
| 00763000271367 | Band 7700FB42 SimuPlus Flex 42mm GLB |
| 00763000271350 | Band 7700FB40 SimuPlus Flex 40mm GLB |
| 00763000271343 | Band 7700FB38 SimuPlus Flex 38mm GLB |
| 00763000271336 | Band 7700FB36 SimuPlus Flex 36mm GLB |
| 00763000271329 | Band 7700FB34 SimuPlus Flex 34mm GLB |
| 00763000271312 | Band 7700FB32 SimuPlus Flex 32mm GLB |
| 00763000271305 | Band 7700FB30 SimuPlus Flex 30mm GLB |
| 00763000271299 | Band 7700FB28 SimuPlus Flex 28mm GLB |
| 00763000271282 | Band 7700FB26 SimuPlus Flex 26mm GLB |
| 00763000414290 | ACCY 7700FS SIMUPLUS R/B SIZERS SIL GLB |
| 00763000414283 | ACCY 7700PS SIMUPLUS R/B SIZERS PS GLB |
Trademark Results [SimuPlus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMUPLUS 88375466 not registered Live/Pending |
Medtronic, Inc 2019-04-08 |
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