Advanced Gynecological Applicator

GUDID 08717213054882

Intrauterine Tube 0mm

Nucletron B.V.

Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Primary Device ID08717213054882
NIH Device Record Keyd00030e6-ab58-4b64-a39c-1c4ac6c13871
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvanced Gynecological Applicator
Version Model Number126013-01
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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
GS108717213054882 [Direct Marking]
GS108717213055001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08717213054882]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-12
Device Publish Date2020-02-04

On-Brand Devices [Advanced Gynecological Applicator]

08717213054325Number Tags For Guiding Tubes
08717213054318Bracelet For Guiding Tubes
08717213054790Interstitial Lunar Ovoid Tube 26mm 60° Right
08717213054783Interstitial Lunar Ovoid Tube 22mm 60° Left
08717213054776Interstitial Lunar Ovoid Tube 22mm 60° Right
08717213055032Intrauterine Tube 40mm 30°
08717213054899Intrauterine Tube 30mm 30°
08717213054882Intrauterine Tube 0mm
08717213054813Interstitial Lunar Ovoid Tube 30mm 60° Left
08717213054806Interstitial Lunar Ovoid Tube 30mm 60° Right
08717213054752Interstitial Lunar Ovoid Tube 26mm 60° Left
08717213054905Vaginal Cap 30mm Left
08717213054912Vaginal Cap 30mm Right
08717213054929Vaginal Cap 26mm Left
08717213055797Vaginal Cap 26mm Right
08717213055773Vaginal Cap 22mm Left
08717213055742Vaginal Cap 22mm Right
08717213055643Interstitial lever
08717213055629Perineal Bar
08717213055599Perineal Template Ventral 0°
08717213055575Perineal Template Dorsal 12°
08717213055551Perineal Template Dorsal 0°
08717213055544Fixation Clip
08717213055513Fixation Element
08717213054844Intrauterine Tube 70mm 15°
08717213055124Intrauterine Tube 60mm 15°
08717213054820Intrauterine Tube 50mm 15°
08717213054868Intrauterine Tube 40mm 15°
08717213054875Intrauterine Tube 30mm 15°
08717213055070Intrauterine Tube 70mm 30°
08717213054851Intrauterine Tube 60mm 30°
08717213054837Intrauterine Tube 50mm 30°

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