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Kosma-Kare

FDA UDI

Class I (US FDA UDI)

by Kosma-Kare Canada Inc

Identity

Trade Name
KOSMA-KARE FDA UDI
Generic Name
Cotton pleats FDA UDI
Device Name
COTTON COIL 12 G/Y - 18LBS /CS FDA UDI
Model / Reference
KC-2292 FDA UDI
Description
COTTON COIL 12 G/Y - 18LBS /CS FDA UDI

Identifiers

Primary DI / UDI-DI
10770619270404 FDA UDI
FDA Product Code
FRL FDA UDI
GMDN Term
Cotton pleats FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cotton pleats

Kosma-Kare by Kosma-Kare Canada Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cotton pleats.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kosma-Kare Canada Inc

Sources (1)

  • FDA UDI 8ca0e828-40a8-45af-b171-76b1a262e7f0 33 fields · synced May 30, 2026