Coolject 1-3cc Syringe Holder Nozzle Accessory

Basic Information

• Brand Name: Coolject 1-3cc Syringe Holder Nozzle Accessory
• Primary DI: 00860006961534
• Version / Model: VM01000-00
• Company Name: Vapocoolshot, Inc
• Labeler DUNS: 032313444
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-27
• Public Version: 1
• Public Version Date: 2023-02-06
• Public Version Status: New
• Public Device Record Key: d3cc9a15-f444-4466-bf84-f5a2c3e59592

Device Description

Coolject 1-3 cc Syringe Holder Nozzle Accessory, One per Box

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• 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
KZH	Introducer, Syringe Needle	General Hospital	880.6920	2
MLY	Vapocoolant Device	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47674	Biopsy syringe holder, reusable	A hand-operated device designed to hold a biopsy syringe to facilitate precision aspiration of a tissue specimen through a biopsy needle. The holder is typically made of metal and plastic materials and typically designed as a lightweight, hand-held frame in which the syringe is placed and its piston withdrawn using a sliding handle in the frame; a stopper may be included to prevent further aspiration at a predetermined point. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860006961534	GS1

Premarket Submissions

Submission Number	Supplement Number
K201248	000