Identity
- Trade Name
- Cryotec FDA UDI
- Generic Name
- Tissue cryostorage straw FDA UDI
- Device Name
- Kitazato Cryotec (10 pieces) (Green) FDA UDI
- Model / Reference
- TEC110G FDA UDI
- Description
- Kitazato Cryotec (10 pieces) (Green) FDA UDI
Identifiers
- Catalog Number
- TEC110G FDA UDI
- Primary DI / UDI-DI
- 04589700010091 FDA UDI
- 510(k) Number
- K162051 FDA UDI
- FDA Product Code
- MQK FDA UDI
- GMDN Term
- Tissue cryostorage straw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6160 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
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cryotec by Reprolife Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Reprolife Inc.
Sources (2)
- FDA UDI 9f82c8ea-3fee-40df-96a6-15edcd327a6b 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026