Coolject 1-3cc Syringe Holder Nozzle Accessory

GUDID 00860006961534

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

Vapocoolshot, Inc

Biopsy syringe holder, reusable

• Primary Device ID: 00860006961534
• NIH Device Record Key: d3cc9a15-f444-4466-bf84-f5a2c3e59592
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coolject 1-3cc Syringe Holder Nozzle Accessory
• Version Model Number: VM01000-00
• Company DUNS: 032313444
• Company Name: Vapocoolshot, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006961534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201248

FDA Product Code

• KZH: Introducer, Syringe Needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-11-19
• Device Publish Date: 2023-01-27

On-Brand Devices [Coolject 1-3cc Syringe Holder Nozzle Accessory]

• 00860006961534: Coolject 1-3 cc Syringe Holder Nozzle Accessory, One per Box
• 00860006961510: Coolject 1-3cc Syringe Holder Nozzle Accessory