FDA UDI
In Commercial Distribution
🇺🇸 United States
MITRACLIP
DI: 08717648230967
·
Model: CDS0701-NTW
·
ABBOTT VASCULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MITRACLIP
- Primary DI
- 08717648230967
- Version / Model
- CDS0701-NTW
- Catalog Number
- CDS0701-NTW
- Company Name
- ABBOTT VASCULAR INC.
- Labeler DUNS
- 964569052
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-11
- Public Version
- 2
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 0b5a1c2c-e695-4fea-8a78-67c9c701e025
Device Description
MitraClip G4 Clip Delivery System NTW
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 | 08717648230967 | 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.