SOL-M Luer Lock Syringe Tray without Needle
by Sol-Millennium Medical, Inc.
Ref 180001TPC, 180001TModel Standard Luer Lock Syringe without Needle
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number081006243SR318US | Date1 Jun 2023 | StatusActive |
| United States | GUDID listing GUDID | Number00818392013009 | Date16 Sep 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- SOL-M Luer Lock Syringe Tray without Needle EUDAMEDSOL-M™ Luer Lock Syringe without Needle GUDID
- Generic Name
- General-purpose syringe, single-use
- Device Name
- SOL-M Luer Lock Syringe without Needle
- Model / Reference
- Standard Luer Lock Syringe without Needle, 180001TPC, 180001T
- Primary DI / UDI-DI
- 00818392013009 EUDAMED00818392013146 EUDAMED10818392013143 GUDID
- Basic UDI-DI
- 081006243SR318US
- Direct Marketing DI
- 0081839201300900818392013146
- FDA Product Code
- FMF
- EMDN Code
- A020102020102 Infusion and irrigation syringes, luer lock cone, 3-piece without needle, single-use
- GMDN Term
- General-purpose syringe, single-use
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 880.5860
- EU market of registration
- Poland
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 1 Milliliter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 00818392013009 00818392013146 | 10818392013143 |
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000010890
- Authorised representative
- Sol-Millennium Europe Sp. z o.o. PL-AR-000010397
Other devices from Sol-Millennium Medical, Inc.
Properties
Other properties (17)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No