Marketlab, Inc

Basic Information

• Brand Name: Marketlab, Inc
• Primary DI: 00817517026825
• Version / Model: 691930
• Company Name: MARKETLAB INC.
• Labeler DUNS: 848917027
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-17
• Public Version: 2
• Public Version Date: 2023-04-07
• Public Version Status: Update
• Public Device Record Key: 938ca6fa-52f3-42ac-bc3a-d363ae40dc36

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KET	Filters, Cell Collection, Tissue Processing	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63784	Histological tissue cassette biopsy insert IVD	A flexible and porous material designed to securely hold a biopsy specimen within a tissue cassette, to prevent loss of the specimen during laboratory specimen processing (e.g., fixation, dehydration, infiltration) in preparation for subsequent cytological or histological examination. The flexible and porous material (e.g., paper, synthetic polymer) is intended to allow infiltration of reagents and maximize fluid-exchange during tissue processing. It is available in various forms (e.g., sheet, bag, foam pad) and is placed in a tissue processing cassette, with the biopsy specimen wrapped or contained inside it. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817517026825	GS1