Identity
- Trade Name
- SOL-CARE™ Luer Lock Syringe with Safety Needle FDA UDI
- Generic Name
- Needle guard FDA UDI
- Device Name
- Used to inject medicines and vaccines into, or withdraw fluids from the body. In addition, the SOL-CARE™ Safety Needle is designed to aid in the prevention of needle stick injuries. 5ml SOL-M LL Syringe with 20g x 1" Safety Needle FDA UDI
- Model / Reference
- 52010SN FDA UDI
- Description
- Used to inject medicines and vaccines into, or withdraw fluids from the body. In addition, the SOL-CARE™ Safety Needle is designed to aid in the prevention of needle stick injuries. 5ml SOL-M LL Syringe with 20g x 1" Safety Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818392012040 FDA UDI
- FDA Product Code
- FMI FDA UDIFMF FDA UDI
- GMDN Term
- Needle guard FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI880.5860 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 — 25 Millimeter FDA UDITotal Volume — 5 Milliliter FDA UDINeedle Gauge — 20 Gauge FDA UDI
Category: General-purpose syringe, single-useNeedle guard
SOL-CARE™ Luer Lock Syringe with Safety Needle by Sol-Millennium Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Needle guard.
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- Portex — ICU MEDICAL, INC. · Class II
- Jelco — ICU MEDICAL, INC. · Class II
- DropSafe Syringe with Safety Needle — HTL STREFA S A · Class II
- Monoject — Cardinal Health 200, LLC · Class II
- EasyPoint® — Retractable Technologies, Inc. · Class II
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
- Sol-Millennium Medical, Inc.
Sources (1)
- FDA UDI b621985b-8461-4f4e-a005-a6773271e3f2 35 fields · synced Jun 9, 2026