Identity
- Trade Name
- Patient Safe Syringe EUDAMEDPatient Safe® FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- Patient Safe Syringe EUDAMED3mL Patient Safe® Syringe FDA UDI
- Model / Reference
- 50301 EUDAMEDFDA UDI
- Description
- 3mL Patient Safe® Syringe FDA UDI
Identifiers
- Catalog Number
- 50301 FDA UDI
- Primary DI / UDI-DI
- 00613703503008 EUDAMEDFDA UDI
- Basic UDI-DI
- 0613703PatientSafePC EUDAMED
- 510(k) Number
- K072654 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A020102010202 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Patient Safe Syringe by Retractable Technologies, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072654 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0613703PatientSafePC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Retractable Technologies, Inc.
- EUDAMED SRN
- US-MF-000031781
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 30975da9-a49e-44ed-8b2a-2c804f332eb7 61 fields · synced Jul 9, 2026
- FDA UDI 673b4a73-f58f-4053-8c99-60f0d26bdaca 36 fields · synced May 30, 2026
- FDA 510(k) K072654 1 fields · synced May 18, 2026