Identity
- Trade Name
- Nidacon FDA UDI
- Generic Name
- Spermatozoa/semen motility medium supplement FDA UDI
- Device Name
- Nidacon's ThermoBlast Thaw Kit for intended to be used with Nidacon’s VitriBlast for optimal recovery of specimens is This product is used for Assisted Reproductive Technology (ART.) procedures. FDA UDI
- Model / Reference
- ThermoBlast™ Kit FDA UDI
- Description
- Nidacon's ThermoBlast Thaw Kit for intended to be used with Nidacon’s VitriBlast for optimal recovery of specimens is This product is used for Assisted Reproductive Technology (ART.) procedures. FDA UDI
Identifiers
- Catalog Number
- TBK-010 FDA UDI
- Primary DI / UDI-DI
- 07350025610252 FDA UDI
- 510(k) Number
- K092107 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- Spermatozoa/semen motility medium supplement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
No
FDA UDI
Category: Spermatozoa/semen motility medium supplement
Nidacon by Nidacon International AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092107 also covers:
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
- Nidacon International AB
Sources (1)
- FDA UDI ff98f927-245d-412b-908c-c1731bac4dee 37 fields · synced May 29, 2026