FDA UDI
In Commercial Distribution
🇺🇸 United States
COR-VALV Aortic retractor cables with fitting
DI: 10817121000201
·
Model: 1011181
·
Coroneo Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- COR-VALV Aortic retractor cables with fitting
- Primary DI
- 10817121000201
- Version / Model
- 1011181
- Catalog Number
- 1011181
- Company Name
- Coroneo Inc
- Labeler DUNS
- 255276362
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-06-30
- Public Version
- 1
- Public Version Date
- 2023-07-10
- Public Version Status
- New
- Public Device Record Key
- 2498d2c9-ba4b-4392-8c18-f3c2069c655d
Device Description
Single-use cables for use with the COR-VALV aortic retractor 1010676.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46774 | Surgical retractor/retraction system blade, reusable | A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00817121000204 | GS1 | ||||
| Primary | 10817121000201 | GS1 |
Customer Contacts
- Phone
- 5143369230
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry.