Identity
- Trade Name
- Medistar/Hatch (Private Label) FDA UDI
- Generic Name
- Vascular catheter introduction needle FDA UDI
- Device Name
- 22GA RW X 5 CM (CALIBRATED FRANSEEN WITH ECHOGENIC TIP) FDA UDI
- Model / Reference
- FNM-2205-UG FDA UDI
- Description
- 22GA RW X 5 CM (CALIBRATED FRANSEEN WITH ECHOGENIC TIP) FDA UDI
Identifiers
- Catalog Number
- FNM-2205-UG FDA UDI
- Primary DI / UDI-DI
- 00859013006031 FDA UDI
- 510(k) Number
- K851831 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Vascular catheter introduction needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 5 Centimeter FDA UDI
Medistar/Hatch (Private Label) by Manan Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Manan Medical Products, Inc.
Sources (1)
- FDA UDI 85e86619-ca76-4773-91bb-0539927f0161 37 fields · synced Jun 6, 2026