Identity
- Trade Name
- Contegra® FDA UDI
- Generic Name
- Pulmonary open-surgery heart valve bioprosthesis FDA UDI
- Device Name
- CNDT 200SH12 CONTEGRA SUPP HDE FDA UDI
- Model / Reference
- 200SH12 FDA UDI
- Description
- CNDT 200SH12 CONTEGRA SUPP HDE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169616837 FDA UDI
- PMA Number
- H020003 FDA UDI
- FDA Product Code
- MWH FDA UDI
- GMDN Term
- Pulmonary open-surgery heart valve bioprosthesis FDA UDI
Classification
- Device Class
- Unclassified FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Pulmonary open-surgery heart valve bioprosthesis
Contegra® by Medtronic, Inc. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulmonary open-surgery heart valve bioprosthesis.
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Cleared under the same submission
H020003 also covers:
- Contegra® — MEDTRONIC, INC.
- Contegra® — MEDTRONIC, INC.
- Contegra® — MEDTRONIC, INC.
- Contegra® — MEDTRONIC, INC.
- Contegra® — MEDTRONIC, INC.
- Contegra® — MEDTRONIC, INC.
- Contegra® — MEDTRONIC, INC.
- Contegra® — MEDTRONIC, INC.
- Contegra® — MEDTRONIC, INC.
- Contegra® — MEDTRONIC, INC.
- Contegra® — MEDTRONIC, INC.
- Contegra® — MEDTRONIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class Unclassified | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 1bb1267a-70c1-41d1-980c-180d267aa0d7 37 fields · synced May 30, 2026