PERL Localization Device, 16Ga x 11.5cm Needle

GUDID 10851766006242

PERL Localization Device, 16Ga x 11.5cm Needle

FOCAL THERAPEUTICS, INC.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable

• Primary Device ID: 10851766006242
• NIH Device Record Key: 5483b58e-b0cd-401a-8505-1a8216b99427
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERL Localization Device, 16Ga x 11.5cm Needle
• Version Model Number: R10
• Company DUNS: 965352946
• Company Name: FOCAL THERAPEUTICS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com
• Phone: 855-764-7258
• Email: customerservice@focalrx.com

Device Dimensions

• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 16 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851766006245 [Primary]
GS1	10851766006242 [Package]; Contains: 00851766006245; Package: Shelf Carton, 5up [5 Units]; In Commercial Distribution
GS1	20851766006249 [Package]; Contains: 00851766006245; Package: Shelf Carton, 1up [1 Units]; In Commercial Distribution

FDA Product Code

• GDF: Guide, Needle, Surgical

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: 2019-07-24
• Device Publish Date: 2019-07-16

On-Brand Devices [PERL Localization Device, 16Ga x 11.5cm Needle]

• 00851766006184: PERL Localization Device, 16Ga x 11.5cm Needle
• 20851766006102: PERL Localization Device, 16Ga x 11.5cm Needle
• 10851766006242: PERL Localization Device, 16Ga x 11.5cm Needle