Contegra®
GUDID 00643169298583
CNDT 200SH12 CONTEGRA GBR1 HDE TEMP IND
MEDTRONIC, INC.
Pulmonary heart valve bioprosthesis| Primary Device ID | 00643169298583 |
| NIH Device Record Key | 77b269ec-64bb-4123-8473-435782751046 |
| Commercial Distribution Status | 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
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 00643169298583 [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 | 3 |
| Public Version Date | 2018-07-06 |
| 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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.