SimuForm™
GUDID 00763000271510
Ring 7800RR34 SimuForm SR 34mm GLB
MEDTRONIC, INC.
Mitral annuloplasty ring| Primary Device ID | 00763000271510 |
| NIH Device Record Key | e7de9ad1-3725-4e42-8987-0288489cb0df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SimuForm™ |
| Version Model Number | 7800RR34 |
| 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
Device Dimensions
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 Millimeter |
| Lumen/Inner Diameter | 34 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000271510 [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 | 2021-05-24 |
| Device Publish Date | 2021-05-15 |
On-Brand Devices [SimuForm™]
| 00763000271572 | ACCY 7800PS SIMUFORM R SIZERS PS |
| 00763000271244 | RING 7800RR40 SIMUFORM SR 40MM US |
| 00763000271237 | RING 7800RR38 SIMUFORM SR 38MM US |
| 00763000271220 | RING 7800RR36 SIMUFORM SR 36MM US |
| 00763000271213 | Ring 7800RR34 SimuForm SR 34mm US |
| 00763000271206 | RING 7800RR32 SIMUFORM SR 32MM US |
| 00763000271190 | RING 7800RR30 SIMUFORM SR 30MM US |
| 00763000271183 | RING 7800RR28 SIMUFORM SR 28MM US |
| 00763000271176 | RING 7800RR26 SIMUFORM SR 26MM US |
| 00763000271169 | RING 7800RR24 SIMUFORM SR 24MM US |
| 00763000271541 | Ring 7800RR40 SimuForm SR 40mm GLB |
| 00763000271534 | Ring 7800RR38 SimuForm SR 38mm GLB |
| 00763000271527 | Ring 7800RR36 SimuForm SR 36mm GLB |
| 00763000271510 | Ring 7800RR34 SimuForm SR 34mm GLB |
| 00763000271503 | Ring 7800RR32 SimuForm SR 32mm GLB |
| 00763000271497 | Ring 7800RR30 SimuForm SR 30mm GLB |
| 00763000271480 | Ring 7800RR28 SimuForm SR 28mm GLB |
| 00763000271473 | Ring 7800RR26 SimuForm SR 26mm GLB |
| 00763000271466 | Ring 7800RR24 SimuForm SR 24mm GLB |
| 00763000414306 | ACCY 7800PS SIMUFORM R SIZERS PS GLB |
Trademark Results [SimuForm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMUFORM 88375459 not registered Live/Pending |
Medtronic, Inc 2019-04-08 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.