MIS Inner Ear Suction Round Knife

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name: MIS Inner Ear Suction Round Knife FDA UDI
Generic Name: Tympanotomy knife, reusable FDA UDI
Device Name: MIS Inner Ear Suction Round Knife 45 Degree 2.5 Millimeter 6.2 Millimeter FDA UDI
Model / Reference: 412-934 FDA UDI
Description: MIS Inner Ear Suction Round Knife 45 Degree 2.5 Millimeter 6.2 Millimeter FDA UDI

Identifiers

Catalog Number: 412-934 FDA UDI
Primary DI / UDI-DI: 00192896121782 FDA UDI
FDA Product Code: LRC FDA UDI
GMDN Term: Tympanotomy knife, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 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

FDA UDI

Sterilization Method

Dry Heat Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 130 Millimeter FDA UDI

Category: Tympanotomy knife, reusable

MIS Inner Ear Suction Round Knife by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Sontec Instruments, Inc.

Sources (1)

FDA UDI a5886afc-cfa0-48ad-b48c-c7fd1329c8e3 36 fields · synced May 30, 2026