the Wand Handpiece

GUDID 20618874000138

WA Handpiece with needle

DCI MANAGEMENT LLC

Dental computer assisted anaesthesia injection handpiece

• Primary Device ID: 20618874000138
• NIH Device Record Key: 78b3b9ac-ee75-4c69-ae99-c7ab30df3120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: the Wand Handpiece
• Version Model Number: WA-2050-305
• Company DUNS: 009143371
• Company Name: DCI MANAGEMENT LLC
• Device Count: 600
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00618874000138 [Unit of Use]
GS1	00618874603052 [Unit of Use]
GS1	20618874000138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961648

FDA Product Code

• EJI: Syringe, Cartridge

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-26

On-Brand Devices [the Wand Handpiece]

• 20618874000138: WA Handpiece with needle
• 20618874000121: WA Handpiece with needle
• 20618874000114: WA Handpiece with needle
• 20618874000107: WA Handpiece without needle