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Kitazato IUI Catheter with Outer Stiffener without Stylet Type3-v2

FDA UDI

Class II (US FDA UDI)

by Kitazato Corporation

Identity

Trade Name
Kitazato IUI Catheter with Outer Stiffener without Stylet Type3-v2 FDA UDI
Generic Name
Assisted reproduction transfer catheter/set FDA UDI
Model / Reference
131180 Type3-v2 FDA UDI

Identifiers

Catalog Number
131180 FDA UDI
Primary DI / UDI-DI
04580303269183 FDA UDI
510(k) Number
K131491 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 with Outer Stiffener without Stylet Type3-v2 by Kitazato Corporation — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Assisted reproduction transfer catheter/set.

Cleared under the same submission

K131491 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kitazato Corporation

Sources (1)

  • FDA UDI 7856a132-03df-435f-a695-a32bb1a6017a 34 fields · synced Jun 8, 2026