Kamiyama

FDA UDI

Class I (US FDA UDI)

by Takayama Instruments Inc.

Identity

Trade Name: Kamiyama FDA UDI
Generic Name: Fascial tissue dilator, reusable FDA UDI
Device Name: Micro Dilator Straight, 185mm, 45degree Tip FDA UDI
Model / Reference: K-500 FDA UDI
Description: Micro Dilator Straight, 185mm, 45degree Tip FDA UDI

Identifiers

Catalog Number: K-500 FDA UDI
Primary DI / UDI-DI: 04580036673196 FDA UDI
FDA Product Code: MDM FDA UDI
GMDN Term: Fascial tissue dilator, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Fascial tissue dilator, reusable

Kamiyama by Takayama Instruments Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ReLine — Nuvasive, Inc. · Class II
Precept — Nuvasive, Inc. · Class II
MIP Minimal Invasive PCNL — Karl Storz GmbH & Co. KG · Class II
Facet Fixation — SeaSpine Orthopedics Corporation · Class I
Facet Fixation — SeaSpine Orthopedics Corporation · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Takayama Instruments Inc.

Sources (1)

FDA UDI 7d13d7cf-f0b5-4ade-b653-031fc72b38c1 34 fields · synced May 30, 2026