Identity
- Trade Name
- Kitazato ET Catheter FDA UDI
- Generic Name
- Assisted reproduction transfer catheter/set FDA UDI
- Model / Reference
- 275128 FDA UDI
Identifiers
- Catalog Number
- 275128 FDA UDI
- Primary DI / UDI-DI
- 04580745042276 FDA UDI
- 510(k) Number
- K162878 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 ET Catheter by Kitazato Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Assisted reproduction transfer catheter/set.
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Cleared under the same submission
K162878 also covers:
- ET CATHETER RYDEN — KITAZATO CORPORATION
- ET CATHETER RYDEN — KITAZATO CORPORATION
- ET CATHETER RYDEN — KITAZATO CORPORATION
- ET CATHETER RYDEN — KITAZATO CORPORATION
- ET Catheter — KITAZATO CORPORATION
- ET Catheter — KITAZATO CORPORATION
- ET Catheter — KITAZATO CORPORATION
- ET Catheter — KITAZATO CORPORATION
- Kitazato ET Catheter — KITAZATO CORPORATION
- Kitazato ET Catheter — KITAZATO CORPORATION
- Kitazato ET Catheter — KITAZATO CORPORATION
- Kitazato ET 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 e4ff8f8b-5cce-42c2-9f85-3ffb39851dc9 34 fields · synced Jun 1, 2026