Identity
- Trade Name
- kitazato IUI Catheter FDA UDI
- Generic Name
- Assisted reproduction transfer catheter/set FDA UDI
- Device Name
- Catheter with Outer Stiffener without Stylet Cannula, 10cm, model number Type4-v3 FDA UDI
- Model / Reference
- 131104 Type4-v3 FDA UDI
- Description
- Catheter with Outer Stiffener without Stylet Cannula, 10cm, model number Type4-v3 FDA UDI
Identifiers
- Catalog Number
- 131104 FDA UDI
- Primary DI / UDI-DI
- 04580303269213 FDA UDI
- 510(k) Number
- K162667 FDA UDI
- FDA Product Code
- MQF FDA UDI
- GMDN Term
- Assisted reproduction transfer catheter/set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6110 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: Assisted reproduction transfer catheter/set
kitazato IUI Catheter by Kitazato Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assisted reproduction transfer catheter/set.
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- VitaVitro — Shenzhen Vitavitro Bio-Tech Co., Ltd. · Class II
- Trackable Intra Uterine Insemination Catheter Open Tip — ALLWIN MEDICAL DEVICES, INC. · Class II
- Labotect — Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung · Class II
- INVENTCATH ECO — LABORATOIRE CCD · Class II
- Wallace Rigid Stylet for 23 cm Catheter — CooperSurgical, Inc. · Class II
Cleared under the same submission
K162667 also covers:
- kitazato IUI Catheter — KITAZATO CORPORATION
- kitazato IUI Catheter — KITAZATO CORPORATION
- kitazato IUI Catheter — KITAZATO CORPORATION
- kitazato IUI Catheter — KITAZATO CORPORATION
- kitazato IUI Catheter — KITAZATO CORPORATION
- kitazato IUI Catheter — KITAZATO CORPORATION
- kitazato IUI Catheter — KITAZATO CORPORATION
- kitazato IUI Catheter — 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 6f6c970c-6dfb-4e7a-a272-613b4d574fea 35 fields · synced Jun 1, 2026