M-Drain® Centesis Catheter

FDA UDI

Class I (US FDA UDI)

by Galt Medical Corp.

Identity

Trade Name: M-Drain® Centesis Catheter FDA UDI
Generic Name: Closed-wound drain, non-bioabsorbable FDA UDI
Device Name: M-Drain® Centesis Catheter FDA UDI
Model / Reference: DRC-011-02 FDA UDI
Description: M-Drain® Centesis Catheter FDA UDI

Identifiers

Catalog Number: D40104010 FDA UDI
Primary DI / UDI-DI: 00841268109094 FDA UDI
FDA Product Code: KGZ FDA UDI
GMDN Term: Closed-wound drain, non-bioabsorbable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 4 French FDA UDI

Category: Closed-wound drain, non-bioabsorbable

M-Drain® Centesis Catheter by Galt Medical Corp. — 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: Galt Medical Corp.

Sources (1)

FDA UDI c3baa28c-c8f6-4c1d-926e-1e3f1b1a1a2f 36 fields · synced Jun 8, 2026