Identity
- Trade Name
- SOL-GUARD™ TB Safety Syringe with Fixed Needle FDA UDI
- Generic Name
- Needle guard FDA UDI
- Device Name
- The SOL-GUARD™ Safety Syringe is intended for the delivery of vaccines. The SOL-GUARD™ Safety Sleeve covers the needle when activated. In the activated position, the Safety Shield guards against accidental needle stick. 1.0ml Safety Syringe with 22g x 1 1/2" needle FDA UDI
- Model / Reference
- 2102215SG FDA UDI
- Description
- The SOL-GUARD™ Safety Syringe is intended for the delivery of vaccines. The SOL-GUARD™ Safety Sleeve covers the needle when activated. In the activated position, the Safety Shield guards against accidental needle stick. 1.0ml Safety Syringe with 22g x 1 1/2" needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818392012835 FDA UDI
- FDA Product Code
- MEG FDA UDI
- GMDN Term
- Needle guard FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
- Needle Gauge — 22 Gauge FDA UDITotal Volume — 1 Milliliter FDA UDILength — 40 Millimeter FDA UDI
Category: General-purpose syringe, single-useNeedle guard
SOL-GUARD™ TB Safety Syringe with Fixed Needle by Sol-Millennium Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 a44a5318-0a91-4394-adfd-b7a985fd019b 35 fields · synced Jun 9, 2026