Fms

FDA UDI

Class II (US FDA UDI)

by DePuy Mitek, Inc.

Identity

Trade Name: FMS FDA UDI
Generic Name: Endoscope sheath, reusable FDA UDI
Device Name: FMS INFLOW/OUTFLOW SHEATH KIT Stopcock Inflow/Outflow Sheath FDA UDI
Model / Reference: 218027 FDA UDI
Description: FMS INFLOW/OUTFLOW SHEATH KIT Stopcock Inflow/Outflow Sheath FDA UDI

Identifiers

Catalog Number: 218027 FDA UDI
Primary DI / UDI-DI: 10886705023783 FDA UDI
510(k) Number: K041824 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Endoscope sheath, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Endoscope sheath, reusable

Fms by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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B.I.O.H. — Karl Storz GmbH & Co. KG · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class I
SpineTIP — Karl Storz GmbH & Co. KG · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II

Cleared under the same submission

K041824 also covers:

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: DePuy Mitek, Inc.

Sources (1)

FDA UDI bd0b5321-97e3-4e3f-a01a-0303337c0086 36 fields · synced May 30, 2026