Identity
- Trade Name
- Kitazato OPU Needle Type2-v6 FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Model / Reference
- 351304 Type2-v6 FDA UDI
Identifiers
- Catalog Number
- 351304 FDA UDI
- Primary DI / UDI-DI
- 04580303269145 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Soft-tissue biopsy procedure kit, non-medicated
The Kitazato OPU Needle Type2-v6 is a single-use, non-medicated needle designed for obstetrics and gynecology. This collection of sterile devices includes the biopsy needle used for non-specific soft tissue biopsies. As a primary product, it has undergone rigorous testing to ensure its safety and efficacy.
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 Reduced Needle Type3-v1 — KITAZATO CORPORATION
- Kitazato OPU Reduced Needle Type3-v2 — KITAZATO CORPORATION
- Kitazato OPU Reduced Needle Type3-v3 — KITAZATO CORPORATION
Authorization Coverage (1 country)
Regulatory Authorizations
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 920c1405-e032-48a8-bc9d-a63a8b289a17 34 fields · synced Jul 31, 2026