Identity
- Trade Name
- Nunc™ IVF ICSI Dish EUDAMEDNunc IVF ICSI Dish FDA UDI
- Generic Name
- Assisted reproduction procedure dish FDA UDI
- Device Name
- IVF Dishes EUDAMEDIVF ICSI DISH FDA UDI
- Model / Reference
- 150265 EUDAMEDFDA UDI
- Description
- IVF ICSI DISH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866630000410 EUDAMEDFDA UDI
- Basic UDI-DI
- 086663000045664897 EUDAMED
- 510(k) Number
- K090429 FDA UDI
- FDA Product Code
- MQK FDA UDI
- EMDN Code
- U080206 CULTURE PLATES FOR ASSISTED REPRODUCTION EUDAMED
- GMDN Term
- Assisted reproduction procedure dish FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6160 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Assisted reproduction procedure dish
Nunc IVF ICSI Dish by Nalge Nunc International Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K090429 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nalge Nunc International Corporation
Sources (2)
- FDA UDI fd80aed5-4d15-47b0-9b5f-6d4b785ff367 34 fields · synced Jun 19, 2026
- EUDAMED c9d6e2d1-324f-400c-8254-53d22211beef 61 fields · synced Jun 19, 2026