FDA UDI
In Commercial Distribution
🇺🇸 United States
Comaneci
DI: 07290015107136
·
Model: ANPP7177
·
RAPID MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Comaneci
- Primary DI
- 07290015107136
- Version / Model
- ANPP7177
- Company Name
- RAPID MEDICAL LTD
- Labeler DUNS
- 532702946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-17
- Public Version
- 3
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- a38456ef-861a-40cc-9136-a4860b5fc302
Device Description
The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms under fluoroscopic guidance. The Comaneci is comprised of a collapsible, fully retrievable, fine wire construction mounted on a wire shaft that expands to comply with the vessel diameter. It is delivered through a neurovascular microcatheter. The Comaneci is provided with a 3.5 French (F) peelable loading sheath.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| PUU | Temporary Coil Embolization Assist Device | Neurology | 882.5955 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46352 | Bare-metal intracranial vascular stent | A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290015107136 | GS1 | ||||
| Package | 17290015107133 | GS1 | 3 | In Commercial Distribution | ||
| Package | 27290015107130 | GS1 | 4 | In Commercial Distribution | ||
| Package | 37290015107137 | GS1 | 2 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN170064 | 000 |