AccessGUDID - DEVICE: MatrixBrush Endometrial Sampler (00869368000202)

GUDID

Device Identifier (DI) Information

Brand Name: MatrixBrush Endometrial Sampler
Version or Model: POI02355
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: POST OAK INNOVATIONS INC

Primary DI Number: 00869368000202
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 060742065 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11531	Endometrial biopsy kit	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFE	Brush, Endometrial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3b31b15d-2bd1-4e84-a942-f3ecb3ca6ea4
Public Version Date: May 01, 2020
Public Version Number: 1
DI Record Publish Date: April 23, 2020