MicroCell

Basic Information

• Brand Name: MicroCell
• Primary DI: 10805360018033
• Version / Model: 15424
• Company Name: VITROLIFE INC.
• Labeler DUNS: 051915038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2018-04-23
• Public Version: 3
• Public Version Date: 2020-04-29
• Public Version Status: Update
• Public Device Record Key: e17f8573-fc1f-46c2-a470-1a078b21b332

Device Description

MicroCell, 20um, 4-Chamber

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: No
• 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
GHO	Hemocytometer	Hematology	864.6160	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
Primary	10805360018033	GS1
Unit of Use	00805360018036	GS1