PERL Localization Device

GUDID 10851766006099

PERL Localization Device, 17Ga x 11.5cm Needle

FOCAL THERAPEUTICS, INC.

Imaging lesion localization marker, implantable
Primary Device ID10851766006099
NIH Device Record Keyae6cb016-c61e-44c7-a162-00e9c72c71dc
Commercial Distribution Discontinuation2017-08-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePERL Localization Device
Version Model NumberR2020
Company DUNS965352946
Company NameFOCAL THERAPEUTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com
Phone855.764.7258
Emailcustomerservice@focalrx.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge17 Gauge
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100851766006092 [Primary]
GS110851766006099 [Package]
Contains: 00851766006092
Package: Shelf Carton [5 Units]
Discontinued: 2017-08-01
Not in Commercial Distribution

FDA Product Code

GDFGuide, Needle, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-05

Devices Manufactured by FOCAL THERAPEUTICS, INC.

10851766006242 - PERL Localization Device, 16Ga x 11.5cm Needle2019-07-24 PERL Localization Device, 16Ga x 11.5cm Needle
00851766006115 - BioZorb LP Marker GOLD2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds
00851766006122 - BioZorb Marker GOLD2018-07-09 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 GOLD2018-07-09 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 GOLD2018-07-09 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 GOLD2018-07-09 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 GOLD2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds
00851766006177 - BioZorb Marker GOLD2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.