BioZorb LP Marker GOLD

GUDID 00851766006115

The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.

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

Primary Device ID	00851766006115
NIH Device Record Key	65ae88fa-5fc8-4237-8592-fd5671b6acc6
Commercial Distribution Status	In Commercial Distribution
Brand Name	BioZorb LP Marker GOLD
Version Model Number	G0231
Company DUNS	965352946
Company Name	FOCAL THERAPEUTICS, INC.
Device Count	1
DM Exempt	true
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	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

Height	1 Centimeter
Height	1 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter
Width	2 Centimeter
Length	3 Centimeter
Height	1 Centimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851766006115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171467

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	2018-07-09
Device Publish Date	2018-06-08

Devices Manufactured by FOCAL THERAPEUTICS, INC.

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00851766006115 - BioZorb LP Marker GOLD	2018-07-09The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
00851766006115 - BioZorb LP Marker GOLD	2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds
00851766006122 - BioZorb Marker GOLD	2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds r
00851766006139 - BioZorb Marker GOLD	2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds r
00851766006146 - BioZorb Marker GOLD	2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds r
00851766006153 - BioZorb Marker GOLD	2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds r
00851766006160 - BioZorb Marker GOLD	2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds
00851766006177 - BioZorb Marker GOLD	2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds