CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory CJ01050-00

GUDID 00860010587317

CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory

Vapocoolshot, Inc

Biopsy syringe holder, reusable

• Primary Device ID: 00860010587317
• NIH Device Record Key: bdbd8b57-0453-40e9-ba13-b6bdf1c5c12f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory
• Version Model Number: CJ01050-00
• Catalog Number: CJ01050-00
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010587317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201248

FDA Product Code

• MLY: Vapocoolant Device

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-11
• Device Publish Date: 2025-08-01

Devices Manufactured by Vapocoolshot, Inc

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