MatrixBrush Endometrial Sampler

Primary DI
00869368000202
Brand
MatrixBrush Endometrial Sampler
Company
POST OAK INNOVATIONS INC
Model
POI02355
Device description
The MatrixBrush Endometrial Sampler is a sterile, single-use endometrial tissue sampling device. The MatrixBrush shaft is comprised of a spirallytwisted 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 anatraumnatic plastic bulb located on the extreme distal end protects the patient from penetration. A moveable plastic sheath overlies the brush head anddevice shaft.
Published
2020-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HFEBrush, Endometrial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFEBrush, EndometrialObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869368000202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869368000202008693680002028693680002020869368000202

GMDN Terms#

Term, Definition table
TermDefinition
Endometrial biopsy kitA collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
(214)219-5880tmorgan@postoakinnovations.com

Regulatory Flags#

DUNS number
060742065
Device count
1
HCT/P
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827002170230TaoCOOK INCORPORATEDHFE2016-09-24
00827002462489TaoCOOK INCORPORATEDHFE2016-09-24
00888937003291UterobrushCoopersurgical, Inc.HFE2016-08-25
20888937003295UterobrushCoopersurgical, Inc.HFE2016-08-25