FDA UDI
In Commercial Distribution
🇺🇸 United States
Perceval S Single Use MICS Accessory Kit
DI: 08022057015259
·
Model: ICV1350
·
CORCYM SRL
Product Codes
0
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Perceval S Single Use MICS Accessory Kit
- Primary DI
- 08022057015259
- Version / Model
- ICV1350
- Company Name
- CORCYM SRL
- Labeler DUNS
- 441454802
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-06
- Public Version
- 7
- Public Version Date
- 2023-02-08
- Public Version Status
- Update
- Public Device Record Key
- 7cf42d12-7e99-41c5-9187-62a91e9c6593
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47680 | Heart valve prosthesis holder, single-use | A hand-held, non-powered, invasive surgical instrument designed to hold a cardiac (heart) valve prosthesis or a cardiac annuloplasty ring at, or in proximity to, its site of implantation during surgery. It includes an implant mounting/containing feature and a handle; implantable devices are not included. This is a single-use device. | No | Active |
| 58707 | Self-expandable heart valve prosthesis post-dilation balloon catheter | A shaft with an inflatable balloon at its distal end intended to be used during open cardiovascular surgery to dilate the inflow ring of a sutureless cardiac (heart) valve prosthesis, after its implantation and self expansion, to facilitate valve sealing and anchoring. It typically includes a Luer connector at the proximal end and is available in a variety of sizes to fit with the valve sizes. This is a single-use device. | No | Active |
| 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 | 08022057015259 | GS1 |