VISICOIL SN-035-005-PL20

GUDID B887SN035005PL200

0.35mm x 0.5cm Gold Fiducial Marker Pre-Loaded Needle 22g x 20cm

RADIOMED CORP

Imaging lesion localization marker, implantable

• Primary Device ID: B887SN035005PL200
• NIH Device Record Key: 7a49a160-a756-4007-80b4-d1a4b626e3d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISICOIL
• Version Model Number: SN-035-005-PL20
• Catalog Number: SN-035-005-PL20
• 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: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com
• Phone: 19014327202
• Email: VISICOIL@izimed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B887SN035005PL200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070305

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-26
• Device Publish Date: 2022-07-18

On-Brand Devices [VISICOIL]

• EIBAKITSPN8PL0: Visicoil Multi-Market Patient Convenience Kit: Quantity of 8: SN-050-005-PL08. Which contains: 0
• EIBAVC110030PL0: 1.10mm x 3.0cm VISICOIL loaded in an 17 gauge brachytherapy needle.
• EIBAVC110020PL300: 1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
• EIBAVC110020PL0: 1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
• EIBAVC110010PL300: 1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
• EIBAVC110010PL0: 1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
• EIBAVC110005PL0: 1.10mm x 0.5cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
• EIBAVC075030PL0: 0.75mm x 3.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC075020PL300: 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC075020PL120: 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC075020PL0: 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC075010PL300: 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC075010PL120: 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC075010PL0: 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC075005PL300: 0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC075005PL120: 0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC075005PL0: 0.75mm x 0.50cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC050020PLSL0: 0.50mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
• EIBAVC050020PL0: 0.5mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC050010PLSL0: 0.5mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
• EIBAVC050010PL300: 0.5mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC050010PL0: 0.50mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC050005PLSL0: 0.50mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
• EIBAVC050005PL300: 0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC050005PL0: 0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
• EIBAVC035040PL0: 0.35mm x 4.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
• EIBAVC035030PL0: 0.35mm x 3.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
• EIBAVC035020PL0: 0.35mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
• EIBAVC035010PL0: 0.35mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
• EIBAVC035005PL0: 0.35mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
• EIBATLS110720170: 2 - 1.10mm x 0.50cm VISICOIL separated by 20mm PGLA spacer (Stranded with PGLA Sleeve) loaded in
• EIBATLS110315170: 2 - 1.10mm x 0.50cm VISICOIL separated by a 15mm PGLA spacer (Stranded with PGLA Sleeve) loaded
• EIBATLS07572018120: 2 - 0.75mm x 0.50cm VISICOIL separated by 20mm PGLA spacer (Stranded with PGLA Sleeve) loaded in
• EIBATLS075720180: 2 - 0.75mm x 0.50cm VISICOIL separated by 20mm PGLA spacer (Stranded with PGLA Sleeve) loaded in
• EIBATLS07531518120: 2 - 0.75mm x 0.50cm VISICOIL separated by 15mm PGLA spacer (Stranded with PGLA Sleeve) loaded in
• EIBATLS075315180: 2 - 0.75mm x 0.50cm VISICOIL separated by a 15mm PGLA Spacer (Stranded with PGLA Sleeve) loaded
• EIBATL110620170: 2 - 1.10mm x 0.50cm VISICOIL separated by a 20mm PGLA spacer (Non-Stranded) loaded in an 17 gaug
• EIBATL110215170: 2 - 1.10mm x 0.50cm VISICOIL separated by a 15mm PGLA spacer (Non-Stranded) loaded in an 17 gaug
• EIBATL07562018120: 2 - 0.75mm x 0.50cm VISICOIL separated by a 20mm PGLA spacer (Non-Stranded) loaded in an 18 gaug
• EIBATL075620180: 2 - 0.75mm x 0.50cm VISICOIL separated by a 20mm PGLA spacer (Non-Stranded) loaded in an 18 gaug
• EIBATL075215180: 2 - 0.75mm x 0.50cm VISICOIL separated by a 15mm PGLA spacer (Non-Stranded) loaded in an 18 gaug
• EIBATL07501518120: 2 - 0.75mm x 0.50cm VISICOIL separated by a 15mm PGLA spacer (Non-Stranded) loaded in an 18 gaug
• EIBATL050620200: 2 - 0.50mm x 0.5cm VISICOIL separated by a 20mm PGLA spacer (Non-Stranded) loaded in an 20 gauge
• EIBATL050215200: 2 - 0.50mm x 0.5cm VISICOIL separated by a 15mm spacer (Non-Stranded) loaded in an 20 gauge pre-
• EIBASN050020PL150: 0.50mm x 2.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
• EIBASN050020PL080: 0.50mm x 2.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
• EIBASN050010PL150: 0.50mm x 1.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
• EIBASN050010PL080: 0.50mm x 1.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
• EIBASN050005PL150: 0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
• EIBASN050005PL080: 0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.