Identity
- Trade Name
- Sydney IVF FDA UDI
- Generic Name
- IVF medium kit FDA UDI
- Device Name
- SYDNEY IVF, BLASTOCYST THAWING KIT FDA UDI
- Model / Reference
- G46293 FDA UDI
- Description
- SYDNEY IVF, BLASTOCYST THAWING KIT FDA UDI
Identifiers
- Catalog Number
- K-SIBT-5000-AA FDA UDI
- Primary DI / UDI-DI
- 00827002462939 FDA UDI
- 510(k) Number
- K152717 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- IVF medium kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Sydney IVF by William A. Cook Australia Pty. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- William A. Cook Australia Pty. Ltd.
Sources (1)
- FDA UDI 45a67179-ee41-4f1c-9388-c219ce07c0d0 38 fields · synced May 30, 2026