X-MARK 001009

GUDID B8870010090

1.15mm x 3cm X-MARK Preloaded

RADIOMED CORP

Imaging lesion localization marker, implantable

• Primary Device ID: B8870010090
• NIH Device Record Key: 80d1c10a-5381-49f2-927d-c0e54f5c37a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-MARK
• Version Model Number: 001009
• Catalog Number: 001009
• Company DUNS: 036545713
• Company Name: RADIOMED CORP
• 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: 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: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com
• Phone: 9014327202
• Email: visicoil@izimed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B8870010090 [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: 2022-06-27
• Device Publish Date: 2022-06-17

On-Brand Devices [X-MARK]

• EIBA10470: 0.45mm x 1cm X-MARK Preloaded (18G)
• EIBA10420: 0.45mm x 3cm X-MARK Loose
• EIBA10410: 0.45mm x 2cm X-MARK Loose
• EIBA10400: 0.45mm x 1cm X-MARKTM Loose
• EIBA10290: 0.85mm x 3cm X-MARK Preloaded
• EIBA10280: 0.85mm x 2cm X-MARK Preloaded
• EIBA10270: 0.85mm x 1cm X-MARK Preloaded
• EIBA10230: 0.85mm x 3cm X-MARKTM Loose
• EIBA10220: 0.85mm x 2cm X-MARK Loose
• EIBA10210: 0.85mm x 1cm X-MARK Loose
• EIBA10090: 1.15mm x 3cm X-MARK Preloaded
• EIBA10080: 1.15mm x 2cm X-MARK Preloaded
• EIBA10070: 1.15mm x 1cm X-MARK Preloaded
• EIBA10030: 1.15mm x 3cm X-MARKTM Loose
• EIBA10020: 1.15mm x 2cm X-MARK Loose
• EIBA10010: 1.15mm x 1cm X-MARK Loose
• B88710470: 0.45mm x 1cm X-MARK Preloaded (18G)
• B88710420: 0.45mm x 3cm X-MARK Loose
• B88710410: 0.45mm x 2cm X-MARK Loose
• B88710400: 0.45mm x 1cm X-MARK Loose
• B88710290: 0.85mm x 3cm X-MARK Preloaded
• B88710280: 0.85mm x 2cm X-MARK Preloaded in 18g Needle
• B88710230: 0.85mm x 3cm X-MARK Loose
• B88710220: 0.85mm x 2cm X-MARK Loose
• B88710210: 0.85mm x 1cm X-MARK Loose
• B88710090: 1.15mm x 3cm X-MARK Preloaded
• B88710080: 1.15mm x 2cm X-MARK Preloaded in 17 g Needle
• B88710070: 1.15mm x 1cm X-MARK Preloaded
• B88710030: 1.15mm x 3cm X-MARK Loose
• B88710020: 1.15mm x 2cm X-MARK Loose
• B88710010: 1.15mm x 1cm X-MARK Loose
• B88710270: 0.85mm x 1cm X-MARK Preloaded in 18g Needle
• B8870010470: 0.45mm x 1cm X-MARK Preloaded (18G)
• B8870010420: 0.45mm x 3cm X-MARK Loose
• B8870010410: 0.45mm x 2cm X-MARK Loose
• B8870010400: 0.45mm x 1cm X-MARK Loose
• B8870010290: 0.85mm x 3cm X-MARK Preloaded
• B8870010280: 0.85mm x 2cm X-MARK Preloaded in 18g Needle
• B8870010270: 0.85mm x 1cm X-MARK Preloaded in 18g Needle
• B8870010230: 0.85mm x 3cm X-MARK Loose
• B8870010220: 0.85mm x 2cm X-MARK Loose
• B8870010210: 0.85mm x 1cm X-MARK Loose
• B8870010090: 1.15mm x 3cm X-MARK Preloaded
• B8870010080: 1.15mm x 2cm X-MARK Preloaded in 17 g Needle
• B8870010070: 1.15mm x 1cm X-MARK Preloaded
• B8870010030: 1.15mm x 3cm X-MARK Loose
• B8870010020: 1.15mm x 2cm X-MARK Loose
• B8870010010: 1.15mm x 1cm X-MARK Loose