Identity
- Trade Name
- Test Tube Heater EUDAMEDCook FDA UDI
- Generic Name
- Test tube heater FDA UDI
- Device Name
- Test Tube Heater EUDAMEDFDA UDI
- Model / Reference
- K-FTH-1012 EUDAMEDG18226 FDA UDI
- Description
- Test Tube Heater FDA UDI
Identifiers
- Catalog Number
- K-FTH-1012 FDA UDI
- Primary DI / UDI-DI
- 00827002182264 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002182264 EUDAMED
- 510(k) Number
- K983609 FDA UDI
- FDA Product Code
- MQG FDA UDI
- EMDN Code
- Z12080299 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Test tube heater FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6120 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Test tube heater
Cook by William A. Cook Australia Pty. Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- William A. Cook Australia Pty. Ltd.
Sources (2)
- FDA UDI 85302ff4-605a-4726-824f-be6cf7d5607d 37 fields · synced Sep 18, 2026
- EUDAMED a88c2728-d4ee-48d0-8ea9-fb5fff56d4ea 61 fields · synced Sep 18, 2026