the Wand STA Handpiece

GUDID 20618874000046

STA Handpiece with needle

DCI MANAGEMENT LLC

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• Primary Device ID: 20618874000046
• NIH Device Record Key: 62da798c-dc76-4f59-bdf3-5d76a80f28a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: the Wand STA Handpiece
• Version Model Number: STA-5050-301
• 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	00618874000046 [Unit of Use]
GS1	00618874603014 [Unit of Use]
GS1	20618874000046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061904

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 STA Handpiece]

• 20618874000053: STA Handpiece with needle
• 20618874000046: STA Handpiece with needle
• 20618874000039: STA Handpiece with needle
• 20618874000022: STA Handpiece without needle