Identity
- Trade Name
- Kitazato OPU Needle FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Model / Reference
- 382124 FDA UDI
Identifiers
- Catalog Number
- 382124 FDA UDI
- Primary DI / UDI-DI
- 04580745041507 FDA UDI
- 510(k) Number
- K162881 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 by Kitazato Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162881 also covers:
- Kitazato OPU Needle — KITAZATO CORPORATION
- Kitazato OPU Needle — KITAZATO CORPORATION
- Kitazato OPU Needle — KITAZATO CORPORATION
- Kitazato OPU Needle — KITAZATO CORPORATION
- Kitazato OPU Needle — KITAZATO CORPORATION
- Kitazato OPU Needle — KITAZATO CORPORATION
- Kitazato OPU Needle — KITAZATO CORPORATION
- Kitazato OPU Needle — KITAZATO CORPORATION
- Kitazato OPU Needle — KITAZATO CORPORATION
- Kitazato OPU Needle — KITAZATO CORPORATION
- Kitazato OPU Needle — KITAZATO CORPORATION
- Kitazato OPU Needle with Connection Tube, Type2-v10 — KITAZATO CORPORATION
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
- Kitazato Corporation
Sources (1)
- FDA UDI 1c311ee9-b133-4965-894f-7bb1a16a3cc6 34 fields · synced Jun 8, 2026