Identity
- Trade Name
- Navylist FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- GUIDEWIRE, 0.018 X 65CM Ni/Tu FDA UDI
- Model / Reference
- H965481080 FDA UDI
- Description
- GUIDEWIRE, 0.018 X 65CM Ni/Tu FDA UDI
Identifiers
- Catalog Number
- 48-108 FDA UDI
- Primary DI / UDI-DI
- 15051684023795 FDA UDI
- 510(k) Number
- K170775 FDA UDI
- FDA Product Code
- DYB FDA UDIGAA FDA UDIGBX FDA UDI
- GMDN Term
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 FDA UDI878.4800 FDA UDI878.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.018 Inch FDA UDILength — 65 Centimeter FDA UDI
Category: Cardiac/peripheral vascular guidewire, single-use
Navylist by Angiodynamics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K170775 also covers:
- ENVI — NAVILYST MEDICAL, INC.
- ENVI — NAVILYST MEDICAL, INC.
- ENVI — NAVILYST MEDICAL, INC.
- ENVI — NAVILYST MEDICAL, INC.
- ENVI — NAVILYST MEDICAL, INC.
- ENVI — NAVILYST MEDICAL, INC.
- ENVI — NAVILYST MEDICAL, INC.
- ENVI — NAVILYST MEDICAL, INC.
- ENVI — NAVILYST MEDICAL, INC.
- ENVI — NAVILYST MEDICAL, INC.
- ENVI — NAVILYST MEDICAL, INC.
- ENVI — NAVILYST MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Angiodynamics, Inc.
Sources (1)
- FDA UDI 8df63a34-305d-458a-9155-bab84abcb707 37 fields · synced Jun 6, 2026