FDA UDI
In Commercial Distribution
🇺🇸 United States
Aortic Prosthesis Indexing Cone
DI: 10817121000171
·
Model: 1010605
·
Coroneo Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Aortic Prosthesis Indexing Cone
- Primary DI
- 10817121000171
- Version / Model
- 1010605
- Catalog Number
- 1010605
- Company Name
- Coroneo Inc
- Labeler DUNS
- 255276362
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-28
- Public Version
- 2
- Public Version Date
- 2023-07-07
- Public Version Status
- Update
- Public Device Record Key
- a5ee3ec9-9799-4c46-a811-475a6f6812f3
Device Description
The Aortic Prosthesis Indexing Cone is a medical device that is intended to be used to facilitate the location and cutting of two or three equally spaced features on an extremity of an aortic graft prosthesis having a diameter within the range of 20 mm to 34 mm.
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44796 | Medical ruler, reusable | A small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws). It is not dedicated to wound measurements. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10817121000171 | GS1 | ||||
| Direct Marking | 00817121000174 | GS1 |
Customer Contacts
- Phone
- +1(514)336-9230
- [email protected]