FDA UDI
In Commercial Distribution
🇺🇸 United States
MitraClip™
DI: 05415067050762
·
Model: CDS0801-XT
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MitraClip™
- Primary DI
- 05415067050762
- Version / Model
- CDS0801-XT
- Catalog Number
- CDS0801-XT
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 149818952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-11
- Public Version
- 1
- Public Version Date
- 2025-12-19
- Public Version Status
- New
- Public Device Record Key
- 42d8c3aa-dbd8-4202-aca4-126fcc921662
Device Description
G5 Delivery System
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| NKM | Mitral valve repair devices | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57790 | Heart valve clip | An implantable device intended for the reconstruction of an insufficient mitral and/or tricuspid heart valve and reduction of valve regurgitation through the fixed approximation of the valve leaflets. It is typically implanted using a percutaneous clip delivery system (CDS) guided by echocardiographic and fluoroscopic imaging. It is typically made of implant grade metal alloys with a polyester fabric cover. Disposable devices associated with implantation (e.g., CDS and accessories) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067050762 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 4.0000 | Millimeter | |
| Width | 22.0000 | Millimeter | |
| Length | 12.0000 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight.