FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MITRACLIP
DI: 08717648195914
·
Model: CDS0201
·
ABBOTT VASCULAR
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MITRACLIP
- Primary DI
- 08717648195914
- Version / Model
- CDS0201
- Catalog Number
- CDS0201
- Company Name
- ABBOTT VASCULAR
- Labeler DUNS
- 849716605
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-11-21
- Public Version
- 3
- Public Version Date
- 2018-05-31
- Public Version Status
- Update
- Public Device Record Key
- 45706367-a8d1-4c90-92da-b9f0b2af3891
- Distribution End Date
- 2018-05-31
Device Description
CLIP DELIVERY SYSTEM, MITRACLIP US
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 |
|---|---|---|---|---|
| 56280 | Mitral valve tissue repair system | A system of devices intended for the percutaneous reconstruction of an insufficient mitral valve through tissue approximation using transvenous/transseptal techniques. It consists of a sterile clip delivery system (CDS), implantable metal clips, steerable delivery and guide catheters with a dilator (acts a conduit), and other devices to be sterilized prior to use. The steerable guide and CDS are typically steered and actuated through the use of control knobs, levers and torque translation techniques and guided by echocardiographic and fluoroscopic imaging. The clip is positioned and the mitral valve leaflets are coapted to reduce mitral regurgitation (MR). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717648195914 | GS1 |
Customer Contacts
- Phone
- +1(800)227-9902
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.