FDA.reportPublic FDA data

PERL Localization Device, 16Ga x 11.5cm Needle

Primary DI
00851766006245
Brand
PERL Localization Device, 16Ga x 11.5cm Needle
Company
FOCAL THERAPEUTICS, INC.
Model
R10
Device description
PERL Localization Device, 16Ga x 11.5cm Needle
Published
2019-07-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDFGuide, Needle, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851766006242PackageGS15Not in Commercial Distribution
20851766006249PackageGS11Not in Commercial Distribution
00851766006245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085176600624210851766006242
2085176600624920851766006249
00851766006245008517660062458517660062450851766006245

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16Gauge

Contacts#

Phone, Email table
PhoneEmail
855-764-7258customerservice@focalrx.com

Regulatory Flags#

DUNS number
965352946
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851766006108PERL Localization Device, 16Ga x 11.5cm NeedleR202017-08-01
00851766006009BioZorb MarkerF02022015-10-26
00851766006016BioZorb MarkerF02032015-10-26
00851766006023BioZorb MarkerF03032015-10-26
00851766006030BioZorb MarkerF03042015-10-26
00851766006047BioZorb MarkerF04042015-10-26
00851766006054BioZorb MarkerF04052015-10-26
00851766006061BioZorb LP MarkerF02212015-10-26
00851766006078BioZorb LP MarkerF02312015-10-26
00851766006085BioZorb LP MarkerF03312015-10-26
00851766006184PERL Localization Device, 16Ga x 11.5cm NeedleR152018-06-08
00851766006092PERL Localization DeviceR20202017-04-05
10851766006242PERL Localization Device, 16Ga x 11.5cm NeedleR102019-07-16
00851766006115BioZorb LP Marker GOLDG02312018-06-08
00851766006122BioZorb Marker GOLDG02032018-06-08
00851766006139BioZorb Marker GOLDG03032018-06-08
00851766006146BioZorb Marker GOLDG03042018-06-08
00851766006153BioZorb Marker GOLDG0203-62018-06-08
00851766006160BioZorb Marker GOLDG0303-62018-06-08
00851766006177BioZorb Marker GOLDG0304-62018-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344044795MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
10197344044801MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
ESAM14762481STOMA®Storz am Mark GmbHGDF2025-04-30
07630037864523APTUSMedartis AGGDF2025-04-08
07630037864547APTUSMedartis AGGDF2025-04-08
07630037864561APTUSMedartis AGGDF2025-04-08
07630037864585APTUSMedartis AGGDF2025-04-08
10197106342312CARDINAL HEALTHCardinal Health 200, LLCGDF2024-04-01
07630037864165APTUSMedartis AGGDF2024-03-22
ESAM14755481STOMA®Storz am Mark GmbHGDF2023-11-20
ESAM14760481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14761481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14750481STOMA®Storz am Mark GmbHGDF2022-11-07
ESAM14751481STOMA®Storz am Mark GmbHGDF2022-11-07
08033860028596BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860028602BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860030353BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
10840199534132Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534149Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534156Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534163Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534170Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534187Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534194Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534200Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534217Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534224Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534231Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534248Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534255Needle HolderKOROS U.S.A., INC.GDF2022-08-01