DentalJect Canister

GUDID 00860010587348

DentalJect Oral Topical Anesthetic Canister; (40gm), One each

Vapocoolshot, Inc

Cold/cool therapy spray

• Primary Device ID: 00860010587348
• NIH Device Record Key: e3079eea-5408-4518-8a83-17cd81f1dce3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentalJect Canister
• Version Model Number: DJ03000-01
• 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: false
• Expiration Date: true
• 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	00860010587348 [Primary]
GS1	10860010587345 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243654

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: 2025-09-16
• Device Publish Date: 2025-09-08

Devices Manufactured by Vapocoolshot, Inc

• 00860010587348 - DentalJect Canister: 2025-09-16DentalJect Oral Topical Anesthetic Canister; (40gm), One each
• 00860010587348 - DentalJect Canister: 2025-09-16 DentalJect Oral Topical Anesthetic Canister; (40gm), One each
• 00860010587379 - DentalJect Applicator Set: 2025-09-16 DentalJect Applicator Set; Contains one DJ01000-00 DentalJect Applicator and one DJ02000-00 DentalJect Syringe Connector
• 00860010587386 - DentalJect Starter Kit: 2025-09-16 DentalJect Starter Kit; Contains one DJ03000-05 Box of 5 canisters, one DJ03000-01 canister, one DJ04000-00 DentalJect Applicato
• 00860010587317 - CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory: 2025-08-11 CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory
• 00860010587324 - CoolJect Targeted-Mist Topical Anesthetic: 2025-08-11 CoolJect Targeted-Mist Topical Anesthetic Canister with Integrated Nozzle (4 Wt. Oz). 1 canister.
• 10860010587321 - CoolJect Targeted-Mist Topical Anesthetic: 2025-08-11 CoolJect Targeted-Mist Topical Anesthetic Canister with Integrated Nozzle (4 Wt. Oz). 12 Canisters per box.
• 00860006961503 - Coolject Topical Anesthetic Canister: 2024-11-19 Coolject Topical Anesthetic Canister
• 00860006961510 - Coolject 1-3cc Syringe Holder Nozzle Accessory: 2024-11-19 Coolject 1-3cc Syringe Holder Nozzle Accessory