Flexible Implant Tubes

GUDID 08717213054240

Radiopaque Button, white 1.7 mm

Nucletron B.V.

General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID08717213054240
NIH Device Record Keybcee5d2b-8716-4cf0-9bf9-5df2fcbe8b65
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexible Implant Tubes
Version Model Number189473-01
Company DUNS415269930
Company NameNucletron B.V.
Device Count6
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 Dimensions

Catheter Gauge5 French

Device Identifiers

Device Issuing AgencyDevice ID
GS108717213053304 [Unit of Use]
GS108717213053458 [Primary]
GS108717213054240 [Package]
Contains: 08717213053458
Package: [12 Units]
In Commercial Distribution

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 Date2020-07-01
Device Publish Date2020-06-23

On-Brand Devices [Flexible Implant Tubes]

08717213054219Radiopaque Button, green 1.9 mm
08717213054202Radiopaque Button, blue 1.9 mm
08717213054189Radiopaque Button, black 1.9 mm
08717213054196Radiopaque Button, red 1.9 mm
08717213054158Flexible Implant Tubes Set, 6F, DL, 30cm
08717213055230Flexible Implant Tubes Set, 6F, SL, 30cm
08717213054165Flexible Implant Tube 5F, DL, 30cm
08717213055254Flexible Implant Tube 5F, SL, 30cm
08717213054172Radiopaque Button, white 1.9 mm
08717213054240Radiopaque Button, white 1.7 mm
08717213054301Radiopaque Button, brown 1.7 mm
08717213054295Radiopaque Button, yellow 1.7 mm
08717213054288Radiopaque Button, green 1.7 mm
08717213054271Radiopaque Button, blue 1.7 mm
08717213054264Radiopaque Button, red 1.7 mm
08717213054257Radiopaque Button, black 1.7 mm
08717213054233Radiopaque Button, brown 1.9 mm
08717213054226Radiopaque Button, yellow 1.9 mm

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