Threaded Spherz

GUDID 00815212020438

Izi Medical Products, LLC

Radiographic image marker, manual Radiographic image marker, manual

• Primary Device ID: 00815212020438
• NIH Device Record Key: de79ddad-ccd1-43ec-9650-9e898642544d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Threaded Spherz
• Version Model Number: TS2003
• 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	00815212020438 [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: 2016-11-10

On-Brand Devices [Threaded Spherz]

• 00815212021565: 2020-40
• 00815212021558: 2020-160
• 00815212021541: 2020-130
• 00815212021534: 2020-120
• 00815212021527: 2020-100
• 00815212021510: 2020-04
• 00815212021503: 2020-03
• 00815212021497: 2020-02
• 00815212021480: 2020-01
• 00815212020469: TS2090
• 00815212020452: TS2005
• 00815212020445: TS2004
• 00815212020438: TS2003
• 00815212020421: TS2002
• 00815212020414: TS2001
• 00815212020407: TS1010
• 00815212024436: 2020-120-CAS