StatLab

Basic Information

• Brand Name: StatLab
• Primary DI: 06971317521769
• Version / Model: CB400-100
• 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: 2024-05-01
• Public Version: 1
• Public Version Date: 2024-05-09
• Public Version Status: New
• Public Device Record Key: ec42da8c-5f53-4ae2-a161-1953fbdb7f32

Device Description

Cervical Papette Cell Collector

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
GEE	Brush, Biopsy, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46388	General-purpose cytology brush	A sterile device consisting of tufts or bristles set into a handle that is intended to collect cells from an area of the body, typically during an open surgical procedure. The cells are used for histopathological analysis. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16971317521766	GS1	Box	100	In Commercial Distribution
Primary	06971317521769	GS1
Package	26971317521763	GS1	Case	20	In Commercial Distribution