Identity
- Trade Name
- Kitazato OPU Reduced Needle Type3-v1 FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Model / Reference
- 341300 Type3-v1 FDA UDI
Identifiers
- Catalog Number
- 341300 FDA UDI
- Primary DI / UDI-DI
- 04580303269152 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 Reduced Needle Type3-v1 by Kitazato Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue biopsy procedure kit, non-medicated.
- QC Auto 20G 20CM 25T 5PK — IZI MEDICAL PRODUCTS LLC · Class II
- TEMNO® — Merit Medical Systems, Inc. · Class II
- MEDONE — Medax Unipersonale Srl · Class II
- QCA-16-6.0-25T — IZI MEDICAL PRODUCTS LLC · Class II
- MAMMOREP LOOP MLX — STERYLAB SRL · Class II
- QCA-12-12.0-25T — IZI MEDICAL PRODUCTS LLC · Class II
- MEDCUT — Medax Unipersonale Srl · Class II
- QC Auto Set 18G 10CM 25T 5PK — IZI MEDICAL PRODUCTS LLC · Class II
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-v5 — KITAZATO CORPORATION
- Kitazato OPU Needle Type2-v6 — KITAZATO CORPORATION
- Kitazato OPU Reduced Needle Type3-v2 — KITAZATO CORPORATION
- Kitazato OPU Reduced Needle Type3-v3 — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kitazato Corporation
Sources (1)
- FDA UDI d1031950-d4a3-4cb1-ada7-d4b017e66e09 34 fields · synced May 30, 2026