FDA UDI
In Commercial Distribution
🇺🇸 United States
Tendyne™
DI: 05415067032720
·
Model: TENDV-SC
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Tendyne™
- Primary DI
- 05415067032720
- Version / Model
- TENDV-SC
- Catalog Number
- TENDV-SC
- 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
- e65cf767-2742-4743-b3f4-ff98e999bb6b
Device Description
Stand Components
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NPU | Prosthesis, mitral valve, percutaneously delivered | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58987 | Self-expandable heart valve bioprosthesis collapsing tool, single-use | A dedicated, manually-operated device designed to reduce the diameter of a self-expanding cardiac valve prosthesis during open and/or transcatheter cardiovascular surgery so the collapsed valve can be mounted onto a dedicated holder or catheter to facilitate implantation. It is available in a variety of designs. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067032720 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P240042 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight