Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene

Basic Information

• Brand Name: Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene
• Primary DI: 10816068020174
• Version / Model: 800097
• Catalog Number: 800097
• Company Name: ADVANCED INSTRUMENTS, INC.
• Labeler DUNS: 125006353
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 96de369a-4001-487f-bc8b-289b6b6ceb81

Device Description

Contains 960 1-200µL pipette tips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
GKL	Counter, Cell, Automated (Particle Counter)	Hematology	864.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16822	Pipette tip	A device formed as a pointed cylindrical tip that is attached to the dispensing opening of a pipette or a dispenser and where the required volume of liquid is drawn for delivery to the target receptacle. It may show a gradient scale or not and is usually made of plastic but may also be made of glass. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10816068020174	GS1
Unit of Use	00816068020177	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K152776	000