Snap On Spherz

GUDID 00815212020537

Izi Medical Products, LLC

Radiographic image marker, manual

• Primary Device ID: 00815212020537
• NIH Device Record Key: e8ccd207-fb7c-4138-b9c3-42b7025c9877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Snap On Spherz
• Version Model Number: PM1010
• 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: false
• 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	00815212020537 [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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-07

On-Brand Devices [Snap On Spherz]

• 00815212022999: PM8012B
• 00815212022937: 2010-40
• 00815212021473: 2010-200
• 00815212021466: 2010-160
• 00815212021459: 2010-130
• 00815212021442: 2010-120
• 00815212021435: 2010-100
• 00815212021411: 2010-04
• 00815212021404: 8100-4004
• 00815212021398: 8100-4003
• 00815212021381: 0100704
• 00815212021374: 0100703
• 00815212021367: 2010-03
• 00815212021350: 2010-02
• 00815212021343: 2010-01
• 00815212020698: PM8108
• 00815212020681: PM8060
• 00815212020674: PM8048
• 00815212020667: PM8035
• 00815212020650: PM8030
• 00815212020643: PM8025
• 00815212020636: PM8020
• 00815212020629: PM8015
• 00815212020612: PM8012
• 00815212020605: PM8010
• 00815212020599: PM8009
• 00815212020582: PM8005
• 00815212020575: PM8004
• 00815212020568: PM8003
• 00815212020551: PM8001
• 00815212020544: PM1010-I
• 00815212020537: PM1010
• 00815212023460: PM8004-7D
• 00815212023453: PM8001-7D
• 00815212024412: 2010-03-ORTHO
• 00815212024405: 2010-120-ORTHO