Gold Fiducial GF1334

GUDID B887GF13340

4 Pack 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle.

RADIOMED CORP

Imaging lesion localization marker, implantable

• Primary Device ID: B887GF13340
• NIH Device Record Key: 33ecede7-874d-450e-9601-4812cbbf0111
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gold Fiducial
• Version Model Number: GF1334
• Catalog Number: GF1334
• Company DUNS: 036545713
• Company Name: RADIOMED CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
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• Email: VISICOIL@izimed.com
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• Email: VISICOIL@izimed.com
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• Email: VISICOIL@izimed.com
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• Email: VISICOIL@izimed.com
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• Email: VISICOIL@izimed.com
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• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
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• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
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• Email: VISICOIL@izimed.com
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• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
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• Email: VISICOIL@izimed.com
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• Email: VISICOIL@izimed.com
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• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
• Phone: +1 901-432-7202
• Email: VISICOIL@izimed.com
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Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B887GF13340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070305

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

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

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

[B887GF13340]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-03
• Device Publish Date: 2022-01-26

On-Brand Devices [Gold Fiducial]

• B887GF1501: 3 Pack - 1.0mm x 5mm Gold Fiducial Marker Loose
• B887GF15010: 1.0mm x 5mm Gold Fiducial Marker Loose
• B887GF03033: 3 Pack, 0.8mm x 3mm Gold Fiducial Marker Loose
• B887GF03020: 0.8mm x 3mm Gold Fiducial Marker Loose
• B887GF10040: 4 Pack - 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle.
• B887GF10030: 3 Pack - 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle.
• B887GF15030: 3 Pack - 1.0mm x 5mm Gold Fiducial Marker Loose
• B887GF13230: 3 Pack - 1.0mm x 3mm Gold Fiducial Marker Pre-Loaded in a 18g x 20cm Needle.
• B887GF03030: 3 Pack, 0.8mm x 3mm Gold Fiducial Marker Loose
• B887GF18230: 3 Pack 1.0mm x 5mm Gold Fiducial Marker Pre-Loaded in a 18g x 20cm Needle.
• B887GF15340: 4 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle.
• B887GF15330: 3 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle.
• B887GF15310: 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle.
• B887GF15240: 4 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle.
• B887GF15230: 3 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle.
• B887GF15210: 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle.
• B887GF13340: 4 Pack 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle.
• B887GF13330: 3 Pack 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle.
• B887GF13310: 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle.
• B887GF13240: 4 Pack - 1.0mm x 3mm Gold Fiducial Marker Pre-Loaded in a 18g x 20cm Needle.