WomanCare Global Flexible Karman Cannula, 10mm

FDA UDI

Class II (US FDA UDI)

by Womancare Global Trading, Inc.

Identity

Trade Name: WomanCare Global Flexible Karman Cannula, 10mm FDA UDI
Generic Name: Intrauterine curette, suction FDA UDI
Device Name: A flexible, sterile cannula with a single large "scoop cut" type opening with no sharp edges. Cannulae feature dots as indicators for measuring the depth of the uterus. Cannulae, regardless of size, have a number identifying the size of cannula. The cannulae are color-coded and use adapters that are also color-coded. This is single-use device, sealed into packaging and sterilized. FDA UDI
Model / Reference: FC10 FDA UDI
Description: A flexible, sterile cannula with a single large "scoop cut" type opening with no sharp edges. Cannulae feature dots as indicators for measuring the depth of the uterus. Cannulae, regardless of size, have a number identifying the size of cannula. The cannulae are color-coded and use adapters that are also color-coded. This is single-use device, sealed into packaging and sterilized. FDA UDI

Identifiers

Primary DI / UDI-DI: 00853615006000 FDA UDI
FDA Product Code: HGH FDA UDI
GMDN Term: Intrauterine curette, suction FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.5070 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

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 223 Millimeter FDA UDI

Category: Intrauterine curette, suction

WomanCare Global Flexible Karman Cannula, 10mm by Womancare Global Trading, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Womancare Global Trading, Inc.

Sources (1)

FDA UDI b51ddef9-d540-448c-abb3-145744b88145 36 fields · synced Jun 1, 2026