Identity
- Trade Name
- SJM™ FDA UDI
- Generic Name
- Heart valve prosthesis holder, single-use FDA UDI
- Model / Reference
- Masters Series Mechanical Heart Valve FDA UDI
Identifiers
- Catalog Number
- A-RHR FDA UDI
- Primary DI / UDI-DI
- 05415067009678 FDA UDI
- FDA Product Code
- DTJ FDA UDI
- GMDN Term
- Heart valve prosthesis holder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.3935 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Heart valve prosthesis holder, single-use
Sjm™ by St. Jude Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heart valve prosthesis holder, single-use.
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- PERCEVAL S — CORCYM SRL · Class III
- PERCEVAL S — Corcym Inc. · Class III
- Perceval S Single Use MICS Accessory Kit — CORCYM SRL
- Perceval RELYON PAK — Corcym Inc. · Class III
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 I | Pending data |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 7e9666b8-a7de-43f6-a1b5-e6c6b608c317 35 fields · synced May 30, 2026