MatrixBrush Endometrial Sampler

FDA UDI

Class II (US FDA UDI)

by Post Oak Innovations, Inc.

Identity

Trade Name: MatrixBrush Endometrial Sampler FDA UDI
Generic Name: Endometrial biopsy kit FDA UDI
Device Name: The MatrixBrush Endometrial Sampler is a sterile, single-use endometrial tissue sampling device. The MatrixBrush shaft is comprised of a spirally twisted stainless steel core covered by plastic with marked gradations. A nylon brush head at the distal end of the device collects a tissue sample and an atraumnatic plastic bulb located on the extreme distal end protects the patient from penetration. A moveable plastic sheath overlies the brush head and device shaft. FDA UDI
Model / Reference: POI02355 FDA UDI
Description: The MatrixBrush Endometrial Sampler is a sterile, single-use endometrial tissue sampling device. The MatrixBrush shaft is comprised of a spirally twisted stainless steel core covered by plastic with marked gradations. A nylon brush head at the distal end of the device collects a tissue sample and an atraumnatic plastic bulb located on the extreme distal end protects the patient from penetration. A moveable plastic sheath overlies the brush head and device shaft. FDA UDI

Identifiers

Primary DI / UDI-DI: 00869368000202 FDA UDI
FDA Product Code: HFE FDA UDI
GMDN Term: Endometrial biopsy kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1100 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

Yes

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

Sterilization Method

Ethylene Oxide FDA UDI

Category: Endometrial biopsy kit

MatrixBrush Endometrial Sampler by Post Oak Innovations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Suresample, Endometrial Sampler — GYNEX CORPORATION · Class II

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: Post Oak Innovations, Inc.

Sources (1)

FDA UDI 3b31b15d-2bd1-4e84-a942-f3ecb3ca6ea4 34 fields · synced May 30, 2026