FDA UDI
In Commercial Distribution
🇺🇸 United States
Tendyne™
DI: 05415067032096
·
Model: TENDV-ST
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Tendyne™
- Primary DI
- 05415067032096
- Version / Model
- TENDV-ST
- Catalog Number
- TENDV-ST
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 149818952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-29
- Public Version
- 1
- Public Version Date
- 2025-06-06
- Public Version Status
- New
- Public Device Record Key
- a7e8c195-3834-48bf-a578-ed3b1ef60283
Device Description
Stand
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NPU | Prosthesis, mitral valve, percutaneously delivered | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60466 | Cardiovascular implant implantation tool base | A plate-like device intended to function as a sturdy support (base) for the holder/implantation tool of a cardiovascular implant (e.g., biologic-polymer aorta graft, heart valve bioprosthesis). It may be made of plastic and/or metallic material and includes means (e.g., slots, posts) for temporary attachment of the holder/implantation tool to enable vertical positioning and/or loading during the procedure. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067032096 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P240042 | 000 |