SIMPLICI-T®
GUDID 00613994759276
BND 670100 SIMPLICI-T ANLPLSTY 10L MEX
MEDTRONIC, INC.
Mitral/tricuspid annuloplasty ring| Primary Device ID | 00613994759276 |
| NIH Device Record Key | f5ac47d6-b195-4575-9443-e279dbc68d57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIMPLICI-T® |
| Version Model Number | 670100 |
| 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 | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 Millimeter |
| Lumen/Inner Diameter | 100 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 *Keep Away From Heat |
| 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 | 00613994759276 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052970
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 | 2015-06-19 |
On-Brand Devices [SIMPLICI-T®]
| 00613994759276 | BND 670100 SIMPLICI-T ANLPLSTY 10L MEX |
| 00763000411367 | BAND 670100 SIMPLICI-T ANNULOPLASTY 10L |
Trademark Results [SIMPLICI-T]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMPLICI-T 78601566 not registered Dead/Abandoned |
Alvarez, Sean 2005-04-04 |
 SIMPLICI-T 78500261 3146593 Live/Registered |
Medtronic, Inc. 2004-10-15 |
 SIMPLICI-T 76427023 2711255 Live/Registered |
DELTACOM, LLC 2002-07-02 |
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