MatrixBrush Endometrial Sampler

GUDID 00869368000202

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.

POST OAK INNOVATIONS INC

Endometrial biopsy kit

• Primary Device ID: 00869368000202
• NIH Device Record Key: 3b31b15d-2bd1-4e84-a942-f3ecb3ca6ea4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MatrixBrush Endometrial Sampler
• Version Model Number: POI02355
• Company DUNS: 060742065
• Company Name: POST OAK INNOVATIONS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (214)219-5880
• Email: tmorgan@postoakinnovations.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869368000202 [Primary]

FDA Product Code

• HFE: Brush, Endometrial

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00869368000202]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-01
• Device Publish Date: 2020-04-23