Identity
- Trade Name
- RZ Medizintechnik GmbH FDA UDI
- Generic Name
- ENFit oral/enteral syringe, reusable FDA UDI
- Device Name
- Ear syringe, 10 ml, all metal chromium plated, for easy continous one hand filling and emptying, Luer-Lock attachme FDA UDI
- Model / Reference
- 410-800-000 FDA UDI
- Description
- Ear syringe, 10 ml, all metal chromium plated, for easy continous one hand filling and emptying, Luer-Lock attachme FDA UDI
Identifiers
- Catalog Number
- 410-800-000 FDA UDI
- Primary DI / UDI-DI
- 04049197310161 FDA UDI
- FDA Product Code
- KYZ FDA UDI
- GMDN Term
- ENFit oral/enteral syringe, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6960 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: ENFit oral/enteral syringe, reusable
RZ Medizintechnik GmbH by RZ-Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
- NeoConnect Oral / Enteral Syringe, OTC — NEOMED, INC. · Class II
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- Piston Irrigation Syringe with Enteral Feeding ENFit Connector Flat Top Syringe — Dynarex Corp. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- RZ-Medizintechnik GmbH
Sources (1)
- FDA UDI bcfb6140-a3e4-4fbe-b1ee-394292e52193 35 fields · synced May 30, 2026