X-MARK Ultra 001062

GUDID B887001062

1.15mm x 3cm Gold Fiducial Marker

RADIOMED CORP

Imaging lesion localization marker, implantable

• Primary Device ID: B887001062
• NIH Device Record Key: 2b1ca63b-e8d6-4032-98b0-745e344ac157
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-MARK Ultra
• Version Model Number: 001062
• Catalog Number: 001062
• Company DUNS: 036545713
• Company Name: RADIOMED CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B887001062 [Primary]

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 [X-MARK Ultra]

• EIBA10790: 0.85mm x 3cm X-MARK ULTRA Preloaded
• EIBA10780: 0.85mm x 2cm X-MARK ULTRA Preloaded
• EIBA10770: 0.85mm x 1cm X-MARKTM ULTRA Preloaded
• EIBA10720: 0.85mm x 3cm X-MARK ULTRA Loose
• EIBA10710: 0.85mm x 2cm X-MARK ULTRA Loose
• EIBA10700: 0.85mm x 1cm X-MARK ULTRA Loose
• EIBA10690: 1.15mm x 3cm X-MARK ULTRA Preloaded
• EIBA10680: 1.15mm x 2cm X-MARK ULTRA Preloaded
• EIBA10670: 1.15mm x 1cm X-MARK ULTRA Preloaded
• EIBA10620: 1.15mm x 3cm X-MARK ULTRA Loose
• EIBA10610: 1.15mm x 2cm X-MARK ULTRA Loose
• EIBA10600: 1.15mm x 1cm X-MARK ULTRA Loose
• B88710790: 0.85mm x 3cm X-MARK ULTRA Preloaded
• B88710780: 0.85mm x 2cm X-MARK ULTRA Preloaded in 18g Needle
• B88710770: 0.85mm x 1cm X-MARKTM ULTRA Preloaded
• B88710720: 0.85mm x 3cm X-MARK ULTRA Loose
• B88710710: 0.85mm x 2cm X-MARK ULTRA Loose
• B88710700: 0.85mm x 1cm X-MARK ULTRA Loose
• B88710690: 1.15mm x 3cm X-MARK ULTRA Preloaded
• B88710680: 1.15mm x 2cm X-MARK ULTRA Preloaded in 17g needle
• B88710670: 1.15mm x 1cm X-MARK ULTRA Preloaded
• B88710620: 1.15mm x 3cm X-MARK ULTRA Loose
• B88710610: 1.15mm x 2cm X-MARK ULTRA Loose
• B88710600: 1.15mm x 1cm X-MARK ULTRA Loose
• B8870010790: 0.85mm x 3cm X-MARK Ultra Preloaded
• B8870010780: 0.85mm x 2cm X-MARK Ultra Preloaded in 18g Needle
• B8870010770: 0.85mm x 1cm X-MARKTM Ultra Preloaded
• B8870010720: 0.85mm x 3cm X-MARK Ultra Loose
• B8870010710: 0.85mm x 2cm X-MARK Ultra Loose
• B8870010700: 0.85mm x 1cm X-MARK Ultra Loose
• B8870010690: 1.15mm x 3cm X-MARK Ultra Preloaded
• B8870010680: 1.15mm x 2cm X-MARK Ultra Preloaded in 17g needle
• B8870010610: 1.15mm x 2cm X-MARK Ultra Loose
• B8870010600: 1.15mm x 1cm X-MARK Ultra Loose
• B887001067: 1.15mm x 1cm Gold Fiducial Marker Pre-Loaded Needle 17g x 20cm
• B887001062: 1.15mm x 3cm Gold Fiducial Marker