Valencia Skin Applicator

GUDID 08717213032071

Valencia Ft Skin Applicator, Ø 20mm

Nucletron B.V.

General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID08717213032071
NIH Device Record Keydd8739cf-7327-4cfd-a9c2-9b26f804010d
Commercial Distribution StatusIn Commercial Distribution
Brand NameValencia Skin Applicator
Version Model Number110821-00
Company DUNS415269930
Company NameNucletron B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Outer Diameter20 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108717213032071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08717213032071]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-30
Device Publish Date2019-09-21

On-Brand Devices [Valencia Skin Applicator]

08717213031852Advanced Skin Applicator Set
08717213032095Valencia Ft Skin Applicator, 30mm
08717213032071Valencia Ft Skin Applicator, Ø 20mm
08717213032057Valencia Skin Applicator, 30mm
08717213032033Valencia Skin Applicator, Ø 20mm

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