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Malecot

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Malecot FDA UDI
Generic Name
Surgical capillary wound drain, luminal, synthetic polymer FDA UDI
Device Name
Silicone Malecot Catheter FDA UDI
Model / Reference
G16925 FDA UDI
Description
Silicone Malecot Catheter FDA UDI

Identifiers

Catalog Number
083820 FDA UDI
Primary DI / UDI-DI
00827002169258 FDA UDI
FDA Product Code
KOB FDA UDI
GMDN Term
Surgical capillary wound drain, luminal, synthetic polymer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5090 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical capillary wound drain, luminal, synthetic polymer

Malecot by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical capillary wound drain, luminal, synthetic polymer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI a9b3b097-4c68-4067-96b1-8ca95f64c430 36 fields · synced Jun 8, 2026