SOL-M Luer Lock Syringe without Needle
by Sol-Millennium Medical, Inc. EUDAMEDGUDID
Active
Ref P180060BSModel Standard Luer Lock Syringe without Needle
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00810018095239 | Date18 Mar 2025 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number081006243SR318US | Date1 Jun 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- SOL-M Luer Lock Syringe without Needle EUDAMEDSOL-M 60ml Luer Lock Syringe w/o Needle (bulk,sterile) GUDID
- Generic Name
- General-purpose syringe, single-use
- Model / Reference
- Standard Luer Lock Syringe without Needle, P180060BS
- Primary DI / UDI-DI
- 00810018095239
- Basic UDI-DI
- 081006243SR318US
- Direct Marketing DI
- 00810018095239
- 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
- Market of Registration
- Poland
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| 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 (18)
- 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No