Simulus™
GUDID 00643169182110
RING SIM SR 800SR24 SEMI-RIGID
MEDTRONIC, INC.
Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral 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 | 00643169182110 |
| NIH Device Record Key | 41e18499-220f-41cc-b07b-1e070bb02469 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Simulus™ |
| Version Model Number | 800SR24 |
| 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 | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Lumen/Inner Diameter | 24 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 *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 *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 *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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169182110 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K072655
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 | 2018-07-06 |
| Device Publish Date | 2015-06-17 |
On-Brand Devices [Simulus™]
| 00613994867148 | RING SIM SR 800SR24 SEMI-RIGID |
| 00613994867094 | RING SIM SR 800SR40 SEMI-RIGID |
| 00613994867001 | RING SIM FR 700FF39 FULLY FLEXIBLE 39MM |
| 00613994866929 | RING SIM FR 700FF23 FULLY FLEXIBLE 23MM |
| 00643169214156 | BAND SIM AA 735AC39 39MM ADJUSTABLE 16L |
| 00643169214132 | BAND SIM AA 735AC37 37MM ADJUSTABLE 16L |
| 00643169214118 | BAND SIM AA 735AC35 35MM ADJUSTABLE 16L |
| 00643169214095 | BAND SIM AA 735AC33 33MM ADJUSTABLE 16L |
| 00643169214071 | BAND SIM AA 735AC31 31MM ADJUSTABLE 16L |
| 00643169214057 | BAND SIM AA 735AC29 29MM ADJUSTABLE 16L |
| 00643169214033 | BAND SIM AA 735AC27 27MM ADJUSTABLE 16L |
| 00643169214019 | BAND SIM AA 735AC25 25MM ADJUSTABLE 16L |
| 00643169182547 | RING SIM 700FF31 FULLY FLEXIBLE |
| 00643169182530 | RING SIM 700FF33 FULLY FLEXIBLE |
| 00643169182523 | RING SIM 700FF35 FULLY FLEXIBLE |
| 00643169182516 | RING SIM 700FF37 FULLY FLEXIBLE |
| 00643169182509 | RING SIM 700FF39 FULLY FLEXIBLE |
| 00643169182493 | BAND SIM 725FC25 FULL FLEXIBLE |
| 00643169182486 | RING SIM 735AF25 25MM ADJUSTABLE |
| 00643169182479 | RING SIM 735AF27 27MM ADJUSTABLE |
| 00643169182462 | RING SIM 735AF29 29MM ADJUSTABLE |
| 00643169182455 | RING SIM 735AF31 31MM ADJUSTABLE |
| 00643169182448 | RING SIM 735AF33 33MM ADJUSTABLE |
| 00643169182431 | RING SIM 735AF35 35MM ADJUSTABLE |
| 00643169182424 | RING SIM 700FF29 FULLY FLEXIBLE |
| 00643169182417 | BAND SIM 700FC23 FULLY FLEXIBLE |
| 00643169182400 | BAND SIM 700FC25 FULLY FLEXIBLE |
| 00643169182394 | BAND SIM 700FC27 FULLY FLEXIBLE |
| 00643169182387 | BAND SIM 700FC29 FULLY FLEXIBLE |
| 00643169182370 | BAND SIM 700FC31 FULLY FLEXIBLE |
| 00643169182363 | BAND SIM 700FC33 FULLY FLEXIBLE |
| 00643169182356 | BAND SIM 700FC35 FULLY FLEXIBLE |
| 00643169182349 | BAND SIM 700FC37 FULLY FLEXIBLE |
| 00643169182332 | BAND SIM 700FC39 FULLY FLEXIBLE |
| 00643169182325 | RING SIM 700FF23 FULLY FLEXIBLE |
| 00643169182318 | RING SIM 700FF25 FULLY FLEXIBLE |
| 00643169182301 | RING SIM 700FF27 FULLY FLEXIBLE |
| 00643169182295 | RING SIM 735AF37 37MM ADJUSTABLE |
| 00643169182288 | RING SIM SR 800SR30 SEMI-RIGID |
| 00643169182271 | RING SIM SR 800SR32 SEMI-RIGID |
| 00643169182264 | RING SIM SR 800SR34 SEMI-RIGID |
| 00643169182257 | RING SIM SR 800SR36 SEMI-RIGID |
| 00643169182240 | RING SIM SR 800SR38 SEMI-RIGID |
| 00643169182233 | RING SIM SR 800SR40 SEMI-RIGID |
| 00643169182226 | RING SIM SR 800SR28 SEMI-RIGID |
| 00643169182219 | RING SIM 735AF39 39MM ADJUSTABLE |
| 00643169182202 | BAND SIM SC 800SC24 SEMI-RIGID |
| 00643169182196 | BAND SIM SC 800SC26 SEMI-RIGID |
| 00643169182189 | BAND SIM SC 800SC28 SEMI-RIGID |
| 00643169182172 | BAND SIM SC 800SC30 SEMI-RIGID |
Trademark Results [Simulus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMULUS 79085926 4103578 Dead/Cancelled |
Agence Spatiale Européenne (ESA) 2010-06-16 |
 SIMULUS 78735472 3287012 Live/Registered |
MEDTRONIC ATS MEDICAL, INC. 2005-10-18 |
 SIMULUS 75530586 2369328 Dead/Cancelled |
Simulus, Ltd. 1998-08-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.