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

• 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