Identity
- Trade Name
- ENVI FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- NEEDLE 21G X 15CM TROCAR STYLET ECHO TIP FDA UDI
- Model / Reference
- 35-504 FDA UDI
- Description
- NEEDLE 21G X 15CM TROCAR STYLET ECHO TIP FDA UDI
Identifiers
- Primary DI / UDI-DI
- H965355040 FDA UDI
- 510(k) Number
- K170775 FDA UDI
- FDA Product Code
- DYB FDA UDIGAA FDA UDIGBX FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable 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
- Length — 15 Centimeter FDA UDILumen/Inner Diameter — 0.5 Millimeter FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Envi by Navilyst Medical, 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:
- Navylist — ANGIODYNAMICS, 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
- Navilyst Medical, Inc.
Sources (1)
- FDA UDI c3b4dab2-34f1-42a9-93cd-44d98dda0ca8 36 fields · synced Jun 1, 2026