Elekta Freiburg Flap

GUDID 08717213060722

Nucletron B.V.

General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID08717213060722
NIH Device Record Key2595696b-0f35-45d9-b919-4244dfb00f4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameElekta Freiburg Flap
Version Model Number592976P01-02
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS108717213060715 [Primary]
GS108717213060722 [Package]
Contains: 08717213060715
Package: [1 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 Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-26
Device Publish Date2025-02-18

Devices Manufactured by Nucletron B.V.

08717213060722 - Elekta Freiburg Flap2025-02-26
08717213060722 - Elekta Freiburg Flap2025-02-26
08717213057203 - Smit Sleeve2024-07-15 Sleeve CT/MR Intrauterine Tube
08717213057258 - Smit Sleeve2024-07-15 Smit Sleeve CT/MR, 4mm
08717213054363 - Luneray2022-11-23 Catheter 6F 50cm, needle 37mm R30mm
08717213054370 - Luneray2022-11-23 Catheter 6F 50cm, needle 47mm R45mm
08717213054387 - Luneray2022-11-23 Catheter 6F 50cm, needle 57mm R60mm
08717213054394 - Luneray2022-11-15 Catheter 6F 50cm, needle 67mm R75mm
08717213057760 - Esteya2022-08-24 Esteya

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