Clip for external cooling
FDA UDIEUDAMEDClass I (US FDA UDI)
by Nouvag AG
Identity
- Trade Name
- Clip for external cooling FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- Irrigation nozzle EUDAMEDClip for external cooling for surgical handpiece 1905/1908 FDA UDI
- Model / Reference
- 1734 EUDAMEDFDA UDI
- Description
- Clip for external cooling for surgical handpiece 1905/1908 FDA UDI
Identifiers
- Primary DI / UDI-DI
- +ENOU17349R EUDAMEDENOU17349 FDA UDI
- Basic UDI-DI
- ++ENOU100032LJ EUDAMED
- FDA Product Code
- GEY FDA UDI
- EMDN Code
- Z12019080,Z12110180,Z12149080 EUDAMED
- GMDN Term
- Surgical irrigation tubing set, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical irrigation tubing set, single-use
Clip for external cooling by Nouvag AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical irrigation tubing set, single-use.
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- Endo-Flo — Davol Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nouvag AG
Sources (2)
- FDA UDI 07f844c1-bf01-4bd8-9e03-fa4cafc434b9 34 fields · synced Jul 28, 2026
- EUDAMED 3bf31a28-5da1-45e8-90a2-372b2372874d 61 fields · synced Jul 28, 2026