Identity
- Trade Name
- Doctors Choice FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- Safety Combo 1 ml LL, 25G x 1" FDA UDI
- Model / Reference
- SYS01250105 FDA UDI
- Description
- Safety Combo 1 ml LL, 25G x 1" FDA UDI
Identifiers
- Primary DI / UDI-DI
- G018SYS012501050 FDA UDI
- 510(k) Number
- K192679 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- General-purpose syringe/needle 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
No
FDA UDI
Over-the-Counter
Yes
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
Category: General-purpose syringe/needle
Doctors Choice by Supply Line International Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose syringe/needle.
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- Azur Medical Company Inc. — Azur Medical Company, Inc. · Class II
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- RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
Cleared under the same submission
K192679 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Supply Line International Medical, LLC
Sources (1)
- FDA UDI a11f7dfa-46a8-422e-803d-04b692490c88 34 fields · synced Jun 8, 2026