Gynosampler

FDA UDI

Class II (US FDA UDI)

by Gynetics Medical Products NV

Identity

Trade Name: Gynosampler FDA UDI
Generic Name: Endometrial biopsy kit FDA UDI
Device Name: The Gynosampler is an endometrial suction curette for a histologic lining biopsy. FDA UDI
Model / Reference: #9164 FDA UDI
Description: The Gynosampler is an endometrial suction curette for a histologic lining biopsy. FDA UDI

Identifiers

Primary DI / UDI-DI: 05425017500377 FDA UDI
510(k) Number: K903002 FDA UDI
FDA Product Code: HFF FDA UDI
GMDN Term: Endometrial biopsy kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1060 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

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 2.93 Millimeter FDA UDI
Length — 262 Millimeter FDA UDI

Category: Endometrial biopsy kit

Gynosampler by Gynetics Medical Products NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endometrial biopsy kit.

Gynex — GYNEX CORPORATION · Class II
Patel Pipelle — TITUS MEDICAL LLC · Class II
Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
Suresample, Endometrial Sampler — GYNEX CORPORATION · Class II
Wallach Endocell — CooperSurgical, Inc. · Class II
Integra® Miltex® — Integra LifeSciences Production Corporation · Class II

Cleared under the same submission

K903002 also covers:

Echosampler — Gynetics Medical Products NV

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: Gynetics Medical Products NV

Sources (1)

FDA UDI c96be6b0-7813-4653-b746-1c139e6f4b25 37 fields · synced May 30, 2026