ProGuide Needles

GUDID 08717213052932

ProGuide Round Needle 6Fx240mm

Nucletron B.V.

General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID08717213052932
NIH Device Record Key663d1874-d636-4ffb-8359-c08aff44a988
Commercial Distribution StatusIn Commercial Distribution
Brand NameProGuide Needles
Version Model Number189688-01
Company DUNS415269930
Company NameNucletron B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(770)300-9725
Emailinfo.america@elekta.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108717213052932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-31
Device Publish Date2020-01-23

On-Brand Devices [ProGuide Needles]

08717213054486ProGuide Round Needle 6Fx294mm
08717213054493ProGuide Sharp Needle 6Fx294mm
08717213054707ProGuide Round Needle 6Fx200mm
08717213054691ProGuide Round Needle 6Fx240mm
08717213054684ProGuide Sharp Needle 5Fx240mm
08717213054677ProGuide Sharp Needle 6Fx200mm
08717213054660ProGuide Sharp Needle 6Fx240mm
08717213054653ProGuide Round Needle Set 6Fx200mm
08717213054646ProGuide Round Needle Set 6Fx240mm
08717213054639ProGuide Sharp Needle Set 5Fx240mm
08717213054622ProGuide Sharp Needle Set 6Fx200mm
08717213054479ProGuide Sharp Needle Set 6Fx240mm
08717213054615ProGuide Sharp Needle 5Fx240mm
08717213054578ProGuide Sharp Needle 6Fx200mm
08717213054530ProGuide Sharp Needle 6Fx240mm
08717213054592ProGuide Sharp Needle 5Fx240mm
08717213054554ProGuide Sharp Needle 6Fx200mm
08717213054523ProGuide Sharp Needle 6Fx240mm
08717213053847ProGuide Round Needle 6Fx200mm
08717213053809ProGuide Round Needle 6Fx240mm
08717213053793ProGuide Round Needle 6Fx200mm
08717213052932ProGuide Round Needle 6Fx240mm
08717213025073ProGuide Obturator 6Fx200 mm
08717213025110ProGuide Obturator 6Fx240 mm
08717213025011ProGuide Obturator 5Fx240 mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.