Identity
- Trade Name
- SOL-CARE Safety Needle FDA UDI
- Generic Name
- Needle guard FDA UDI
- Device Name
- SOL-CARE Safety Needle 25Gx1 1/2 FDA UDI
- Model / Reference
- PSN2515 FDA UDI
- Description
- SOL-CARE Safety Needle 25Gx1 1/2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818392018561 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Needle guard FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
- Needle Gauge — 25 Gauge FDA UDILength — 40 Millimeter FDA UDI
Category: Hypodermic needle, single-useNeedle guard
SOL-CARE Safety Needle by Sol-Millennium Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sol-Millennium Medical, Inc.
Sources (2)
- FDA UDI 1bde5fb1-da67-4555-9d36-81bc7744c75c 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026