Contegra®
GUDID 00613994600134
CNDT 200SH12 CONTEGRA SUPP HDE GBR1-PS
MEDTRONIC, INC.
Pulmonary heart valve bioprosthesis Pulmonary heart valve bioprosthesis Pulmonary heart valve bioprosthesis Pulmonary heart valve bioprosthesis Pulmonary heart valve bioprosthesis Pulmonary heart valve bioprosthesis Pulmonary heart valve bioprosthesis Pulmonary heart valve bioprosthesis Pulmonary heart valve bioprosthesis Pulmonary heart valve bioprosthesis Pulmonary heart valve bioprosthesis Pulmonary heart valve bioprosthesis Pulmonary heart valve bioprosthesis| Primary Device ID | 00613994600134 |
| NIH Device Record Key | 8cd2072e-5bae-4bd4-9f46-2157e171de2b |
| Commercial Distribution Discontinuation | 2018-10-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Contegra® |
| Version Model Number | 200SH12 |
| 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
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994600134 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- H020003
FDA Product Code
| MWH | pulmonic valved conduit |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-12-19 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [Contegra®]
| 00613994600349 | CNDT 200H22 CONTEGRA UNSUPP HDE PS |
| 00613994600325 | CNDT 200H20 CONTEGRA UNSUPP HDE PS |
| 00613994600301 | CNDT 200H18 CONTEGRA UNSUPP HDE PS |
| 00613994600295 | CNDT 200H16 CONTEGRA UNSUPP HDE GBR1-PS |
| 00613994600288 | CNDT 200H16 CONTEGRA UNSUPP HDE PS |
| 00613994600271 | CNDT 200H14 CONTEGRA UNSUPP HDE GBR1-PS |
| 00613994600257 | CNDT 200H12 CONTEGRA UNSUPP HDE GBR1-PS |
| 00613994600226 | CNDT 200SH22 CONTEGRA SUPP HDE PS |
| 00613994600202 | CNDT 200SH20 CONTEGRA SUPP HDE PS |
| 00613994600189 | CNDT 200SH18 CONTEGRA SUPP HDE PS |
| 00613994600172 | CNDT 200SH16 CONTEGRA SUPP HDE GBR1-PS |
| 00613994600165 | CNDT 200SH16 CONTEGRA SUPP HDE PS |
| 00613994600158 | CNDT 200SH14 CONTEGRA SUPP HDE GBR1-PS |
| 00613994600141 | CNDT 200SH14 CONTEGRA SUPP HDE PS |
| 00613994600134 | CNDT 200SH12 CONTEGRA SUPP HDE GBR1-PS |
| 00643169616943 | CNDT 200H22 CONTEGRA UNSUPP HDE |
| 00643169616936 | CNDT 200H20 CONTEGRA UNSUPP HDE |
| 00643169616929 | CNDT 200H18 CONTEGRA UNSUPP HDE |
| 00643169616912 | CNDT 200H16 CONTEGRA UNSUPP HDE |
| 00643169616905 | CNDT 200H14 CONTEGRA UNSUPP HDE |
| 00643169616899 | CNDT 200H12 CONTEGRA UNSUPP HDE |
| 00643169616882 | CNDT 200SH22 CONTEGRA SUPP HDE |
| 00643169616875 | CNDT 200SH20 CONTEGRA SUPP HDE |
| 00643169616868 | CNDT 200SH18 CONTEGRA SUPP HDE |
| 00643169616851 | CNDT 200SH16 CONTEGRA SUPP HDE |
| 00643169616844 | CNDT 200SH14 CONTEGRA SUPP HDE |
| 00643169616837 | CNDT 200SH12 CONTEGRA SUPP HDE |
| 00643169357167 | CNDT 200SH22 CONTEGRA GBR1 HDE TEMP IND |
| 00643169357150 | CNDT 200SH20 CONTEGRA GBR1 HDE TEMP IND |
| 00643169357143 | CNDT 200SH18 CONTEGRA GBR1 HDE TEMP IND |
| 00643169357136 | CNDT 200H22 CONTEGRA GBR1 HDE TEMP IND |
| 00643169357129 | CNDT 200H20 CONTEGRA GBR1 HDE TEMP IND |
| 00643169357112 | CNDT 200H18 CONTEGRA GBR1 HDE TEMP IND |
| 00643169298644 | CNDT 200H12 CONTEGRA GBR1 HDE TEMP IND |
| 00643169298637 | CNDT 200H14 CONTEGRA GBR1 HDE TEMP IND |
| 00643169298620 | CNDT 200H16 CONTEGRA GBR1 HDE TEMP IND |
| 00643169298613 | CNDT 200H18 CONTEGRA GBR3 HDE TEMP IND |
| 00643169298606 | CNDT 200H20 CONTEGRA GBR3 HDE TEMP IND |
| 00643169298590 | CNDT 200H22 CONTEGRA GBR3 HDE TEMP IND |
| 00643169298583 | CNDT 200SH12 CONTEGRA GBR1 HDE TEMP IND |
| 00643169298576 | CNDT 200SH14 CONTEGRA GBR1 HDE TEMP IND |
| 00643169298569 | CNDT 200SH16 CONTEGRA GBR1 HDE TEMP IND |
| 00643169298552 | CNDT 200SH18 CONTEGRA GBR3 HDE TEMP IND |
| 00643169298545 | CNDT 200SH20 CONTEGRA GBR3 HDE TEMP IND |
| 00643169298538 | CNDT 200SH22 CONTEGRA GBR3 HDE TEMP IND |
Trademark Results [Contegra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CONTEGRA 78183612 2833310 Live/Registered |
CONTEGRA SYSTEMS, INC. 2002-11-11 |
 CONTEGRA 75773312 2649853 Live/Registered |
MEDTRONIC, INC. 1999-08-11 |
 CONTEGRA 75413341 2322266 Live/Registered |
Contegra Inc. 1997-12-31 |
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