SOL-M Luer Lock Syringe without Needle (PP)
by Sol-Millennium Medical, Inc.
Ref P180001PPModel Standard Luer Lock Syringe without Needle (low dead space)
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 | Number081006243SR313UG 10818392018162 | Date31 May 2023 | StatusActive |
| United States | GUDID listing GUDID | Number10818392018162 | Date12 Apr 2019 | 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- Withdrawn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 without Needle (PP) EUDAMEDSOL-M Syringe GUDID
- Generic Name
- General-purpose syringe, single-use
- Device Name
- SOL-M Luer Lock Syringe w/o Needle (PP)
- Model / Reference
- Standard Luer Lock Syringe without Needle (low dead space), P180001PP
- Primary DI / UDI-DI
- 10818392018162 EUDAMED00818392018165 GUDID
- Basic UDI-DI
- 081006243SR313UG
- Direct Marketing DI
- 10818392018162
- FDA Product Code
- FMF, QNQ
- 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 | 10818392018162 | 00818392018165 |
| 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