Identity
- Trade Name
- Kitazato OPU Needle Type2-v5 FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Model / Reference
- 350304 Type2-v5 FDA UDI
Identifiers
- Catalog Number
- 350304 FDA UDI
- Primary DI / UDI-DI
- 04580303269121 FDA UDI
- 510(k) Number
- K112462 FDA UDI
- FDA Product Code
- MQE FDA UDI
- GMDN Term
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6100 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Soft-tissue biopsy procedure kit, non-medicated
Kitazato OPU Needle Type2-v5 by Kitazato Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K112462 also covers:
- Kitazato OPU Needle Type2-v1 — KITAZATO CORPORATION
- Kitazato OPU Needle Type2-v2 — KITAZATO CORPORATION
- Kitazato OPU Needle Type2-v3 — KITAZATO CORPORATION
- Kitazato OPU Needle Type2-v4 — KITAZATO CORPORATION
- Kitazato OPU Needle Type2-v5 — KITAZATO CORPORATION
- Kitazato OPU Needle Type2-v6 — KITAZATO CORPORATION
- Kitazato OPU Reduced Needle Type3-v1 — KITAZATO CORPORATION
- Kitazato OPU Reduced Needle Type3-v2 — KITAZATO CORPORATION
- Kitazato OPU Reduced Needle Type3-v3 — KITAZATO CORPORATION
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
- Kitazato Corporation
Sources (2)
- FDA UDI 77581073-1cd5-410b-919f-f957c57d8e1d 34 fields · synced May 30, 2026
- EUDAMED 1 fields · synced May 22, 2026