StatLab

Basic Information

• Brand Name: StatLab
• Primary DI: 06971317522315
• Version / Model: 050-1S
• Company Name: Yancheng Huida Medical Instruments Co., Ltd.
• Labeler DUNS: 543621553
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-10
• Public Version: 1
• Public Version Date: 2025-04-18
• Public Version Status: New
• Public Device Record Key: 271246e5-30b6-4899-aafc-59a7684d577f

Device Description

Sterile Microscope Slides White Tab

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: Yes
• 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
Package	16971317522312	GS1	box	50	In Commercial Distribution
Primary	06971317522315	GS1
Package	26971317522319	GS1		20	In Commercial Distribution