StatLab

Basic Information

• Brand Name: StatLab
• Primary DI: 04250317357373
• Version / Model: Millennia ground egdes white marking area
• Catalog Number: 318
• Company Name: Paul Marienfeld GmbH & Co. KG
• Labeler DUNS: 315050401
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 72
• Record Status: Published
• Publish Date: 2024-04-26
• Public Version: 1
• Public Version Date: 2024-05-06
• Public Version Status: New
• Public Device Record Key: 15773ce3-aada-407d-b0ac-ca557fff5915

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KEW	Slides, Microscope	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57925	General specimen microscopy slide IVD, single-use	A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04250317387592	GS1
Primary	04250317357373	GS1