FDA.reportPublic FDA data

ProGuide Needles

Primary DI
08717213054530
Brand
ProGuide Needles
Company
Nucletron B.V.
Model
189684-01
Device description
ProGuide Sharp Needle 6Fx240mm
Published
2020-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAQSystem, applicator, radionuclide, remote-controlled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060349000PROGUIDE NEEDLE SETNucletron Corporation2006-03-10JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717213054530PackageGS110In Commercial Distribution
08717213053816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717213054530087172130545308717213054530
08717213053816087172130538168717213053816

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose brachytherapy system applicator, remote-afterloadingA general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area. This device includes a variety of applicators (e.g., hollow needle, tube, catheter), and their associated components [e.g., introducer sheath, guidewire].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(770)300-9725info.america@elekta.com

Regulatory Flags#

DUNS number
415269930
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717213060746Rectal Applicator153106-012026-04-20
08717213060937Fixation Element153202-012026-04-20
08717213060951Fixation Clip153203-012026-04-20
08717213060975Insertion Tool153204-012026-04-20
08717213055919Geneva152001-002020-08-12
08717213055933Geneva152002-002020-08-15
08717213055957Geneva152003-002020-08-13
08717213055971Geneva152004-002020-08-13
08717213055995Geneva152005-002020-08-13
08717213056015Geneva152006-002020-08-15
08717213056039Geneva152007-002020-08-14
08717213056053Geneva152008-002020-08-15
08717213056077Geneva152009-002020-08-14
08717213056091Geneva152010-002020-08-14
08717213056299Geneva152037-002020-08-14
08717213056312Geneva152038-002020-08-14
08717213056336Geneva152039-002020-08-14
08717213056398Geneva152011-002020-08-13
08717213056411Geneva152012-002020-08-15
08717213056435Geneva152013-002020-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816389028081MAASTRO Rectal Applicator Set, ΓΈ 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-06-02
08717213014305NANucletron B.V.JAQ2019-02-02
08717213008472Shielded Cylindrical ApplicatorNucletron B.V.JAQ2018-07-11
08717213008892NANucletron B.V.JAQ2018-07-11
08717213008908NANucletron B.V.JAQ2018-07-11
08717213008915NANucletron B.V.JAQ2018-07-11
08717213009578Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009585Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009646Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213007772Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007796Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007826Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009660Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009677Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009691Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213010000Flexible Implant TubesNucletron B.V.JAQ2018-07-06
08717213010024Flexible Implant TubesNucletron B.V.JAQ2018-07-06
08717213009318Esophageal ApplicatorNucletron B.V.JAQ2018-06-27
08717213010666Flexible Implant TubesNucletron B.V.JAQ2018-06-27
08717213007765Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213009042Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213009059Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213013926Vaginal CT/MR ApplicatorNucletron B.V.JAQ2018-06-20
08717213008274MicroSelectron DigitalNucletron B.V.JAQ2018-06-14
08717213014022Standard CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014039Standard CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014145Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014152Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014169Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014206Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09