MedGyn Flexible/Karman Cannula-Curette 11mm

FDA UDI

Class I (US FDA UDI)

by Medgyn Products, Inc.

Identity

Trade Name: MedGyn Flexible/Karman Cannula-Curette 11mm FDA UDI
Generic Name: Intrauterine cannula, single-use FDA UDI
Device Name: 12mm Flexible/Karman Curette FDA UDI
Model / Reference: 12mm Flexible/Karman Curette FDA UDI
Description: 12mm Flexible/Karman Curette FDA UDI

Identifiers

Catalog Number: 022012K FDA UDI
Primary DI / UDI-DI: M803K022012 FDA UDI
FDA Product Code: HCY FDA UDI
GMDN Term: Intrauterine cannula, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.4530 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Intrauterine cannula, single-use

MedGyn Flexible/Karman Cannula-Curette 11mm by Medgyn Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MedGyn Flexible/Karman Cannula-Curette 8mm — MEDGYN PRODUCTS, INC. · Class I

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: Medgyn Products, Inc.

Sources (1)

FDA UDI c9bd226a-3cf5-48a2-bf69-983d20edfc73 34 fields · synced Jun 8, 2026