VISICOIL MR SHZ-035-010-22

GUDID SHZ03501022

0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.

RADIOMED CORP

Imaging lesion localization marker, implantable

• Primary Device ID: SHZ03501022
• NIH Device Record Key: 16b3a8be-f959-4551-b80d-1880d36fbd28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISICOIL MR
• Version Model Number: SHZ-035-010-22
• Catalog Number: SHZ-035-010-22
• 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@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com
• Phone: +1 901-432-7202
• Email: visicoil@iba-group.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	SHZ03501022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161724

FDA Product Code

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

Sterilization

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

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

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Ethylene Oxide

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[SHZ03501022]

Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

[SHZ03501022]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-26
• Device Publish Date: 2021-04-16

On-Brand Devices [VISICOIL MR]

• EIBASNMR05001021200: 0.50mm x 01.0cm VISICOIL MR Platinum loaded in an 21 gauge 20cm pre-waxed needle.
• EIBASNMR05001021150: 0.50mm x 01.0cm VISICOIL MR Platinum loaded in an 21 gauge 15cm pre-waxed needle.
• EIBASNMR05000521200: 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 20cm pre-waxed needle
• EIBASNMR05000521150: 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 15cm pre-waxed needle.
• EIBASNMR05000521080: 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 8cm pre-waxed needle.
• EIBASNMR03503022200: 0.35mm x 3.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.
• EIBASNMR03502022200: 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.
• EIBASNMR03502022150: 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle.
• EIBASNMR03502022080: 0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle.
• EIBASNMR03501022200: 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.
• EIBASNMR03501022150: 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle.
• EIBASNMR03501022080: 0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle.
• EIBASNMR03500522200: 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22g 20cm pre-waxed needle.
• EIBASNMR03500522150: 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22g 15cm pre-waxed needle.
• EIBASNMR03500522080: 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22 gauge 8cm pre-waxed needle.
• EIBAMRFP1000200: 1.00 mm x 2.0 cm VISICOIL MR Platinum Fiducial Tissue Marker
• EIBAMRFP1000100: 1.00 mm x 1.0 cm VISICOIL MR Fiducial Tissue Marker
• EIBAMRFP1000050: 1.00 mm x 0.5 cm VISICOIL MR Fiducial Tissue Marker
• EIBAMRFP0750200: 0.75 mm x 2.0 cm VISICOIL MR Platinum Fiducial Tissue Marker
• EIBAMRFP0750100: 0.75 mm x 1.0 cm VISICOIL MR Fiducial Tissue Marker
• EIBAMRFP0750050: 0.75 mm x 0.5 cm VISICOIL MR Fiducial Tissue Marker
• EIBAMRFP0500200: 0.50 mm x 2 cm VISICOIL MR Platinum Fiducial Tissue Marker
• EIBAMRFP0500100: 0.50 mm x 1 cm VISICOIL MR Fiducial Tissue Marker
• EIBAMRFP0500050: 0.50 mm x 0.5 cm VISICOIL MR Fiducial Tissue Marker
• EIBAMRFP0350200: 0.35 mm x 2 cm VISICOIL MR Platinum Fiducial Tissue Marker
• EIBAMRFP0350100: 0.35 mm x 1 cm VISICOIL MR Fiducial Tissue Marker
• EIBAMRFP0350050: 0.35 mm x 0.5 cm VISICOIL MR Fiducial Tissue Marker
• EIBAMR075010PL0: 0.75mm x 1.0cm VISICOIL MR Platinum loaded in a 19 gauge 20cm pre-waxed needle
• EIBAMR075005PL0: 0.75mm x 0.5cm VISICOIL MR Platinum loaded in a 19 gauge 20cm pre-waxed needle
• EIBAMR050010PL0: 0.50mm x 1.0cm VISICOIL MR Platinum loaded in a 20 gauge 20cm pre-waxed needle
• EIBAMR050005PL0: 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 20 gauge 20cm pre-waxed needle
• EIBAMR005005PL0: 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 20 gauge 20cm pre-waxed needle
• B887SNMR05001021200: 0.50mm x 01.0cm VISICOIL MR Platinum loaded in an 21 gauge 20cm pre-waxed needle.
• B887SNMR05001021150: 0.50mm x 01.0cm VISICOIL MR Platinum loaded in a 21 gauge 15cm pre-waxed needle.
• B887SNMR05000521150: 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 15cm pre-waxed needle.
• B887SNMR05000521080: 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 8cm pre-waxed needle.
• B887SNMR03503022200: 0.35mm x 3.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.
• B887SNMR03502022200: 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.
• B887SNMR03502022150: 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle.
• B887SNMR03502022080: 0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle.
• B887SNMR03501022200: 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.
• B887SNMR03501022150: 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle.
• B887SNMR03501022080: 0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle.
• B887SNMR03500522200: 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22g 20cm pre-waxed needle.
• B887SNMR03500522150: 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22g 15cm pre-waxed needle.
• B887SNMR03500522080: 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22 gauge 8cm pre-waxed needle.
• B887MRFP1000200: 1.00 mm x 2.0 cm VISICOIL MR Platinum Fiducial Tissue Marker
• B887MRFP1000100: 1.00 mm x 1.0 cm VISICOIL MR Fiducial Tissue Marker
• B887MRFP1000050: 1.00 mm x 0.5 cm VISICOIL MR Fiducial Tissue Marker
• B887MRFP0750200: 0.75 mm x 2.0 cm VISICOIL MR Platinum Fiducial Tissue Marker