FDA UDI
In Commercial Distribution
🇺🇸 United States
Navylist
DI: H965481080
·
Model: 48-108
·
NAVILYST MEDICAL, INC.
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Navylist
- Primary DI
- H965481080
- Version / Model
- 48-108
- Company Name
- NAVILYST MEDICAL, INC.
- Labeler DUNS
- 809699023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-07
- Public Version
- 5
- Public Version Date
- 2021-09-28
- Public Version Status
- Update
- Public Device Record Key
- cc40e5db-d92a-4f7d-97e9-f0e30f614f99
Device Description
GUIDEWIRE, 0.018 X 65CM Ni/Tu
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
- 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 |
|---|---|---|---|---|
| GAA | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | General, Plastic Surgery | 878.4800 | 1 |
| GBX | CATHETER, IRRIGATION | General, Plastic Surgery | 878.4200 | 1 |
| DYB | INTRODUCER, CATHETER | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35094 | Cardiac/peripheral vascular guidewire, single-use | A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | H965481080 | HIBCC | ||||
| Package | H965481081 | HIBCC | BOX | 10 | In Commercial Distribution | |
| Secondary | 15051684023795 | GS1 |
Customer Contacts
- Phone
- +1(518)795-1676
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170775 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.018 | Inch | |
| Length | 65 | Centimeter |