Simulus™
GUDID 00643169182400
BAND SIM 700FC25 FULLY FLEXIBLE
MEDTRONIC, INC.
Mitral/tricuspid annuloplasty ring| Primary Device ID | 00643169182400 |
| NIH Device Record Key | 63db9870-4e01-4655-9394-dac0fef8693e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Simulus™ |
| Version Model Number | 700FC25 |
| 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 | 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 |
| 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 |
| 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 *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 | 00643169182400 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052899
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 |
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