Quick Spherz

GUDID 00815212020513

Izi Medical Products, LLC

Radiographic image marker, manual

• Primary Device ID: 00815212020513
• NIH Device Record Key: 30e7058e-b0cb-4cf7-b3a4-92816b339c0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quick Spherz
• Version Model Number: QS7005
• Company DUNS: 933506164
• Company Name: Izi Medical Products, LLC
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815212020513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022074

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

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: 2016-11-03

On-Brand Devices [Quick Spherz]

• 00815212021657: 2021-40
• 00815212021640: 2021-160
• 00815212021633: 2021-130
• 00815212021626: 2021-120
• 00815212021619: 2021-100
• 00815212021602: 2021-04
• 00815212021596: 2021-03
• 00815212021572: 2021-01
• 00815212020520: QS7090
• 00815212020513: QS7005
• 00815212020506: QS7004
• 00815212020490: QS7003
• 00815212020483: QS7002
• 00815212020476: QS7001