Smit Sleeve

GUDID 08717213057258

Smit Sleeve CT/MR, 4mm

Nucletron B.V.

Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Primary Device ID08717213057258
NIH Device Record Key3ebfb8f7-6afb-490c-ae03-0d0358f175d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmit Sleeve
Version Model Number129117-00
Company DUNS415269930
Company NameNucletron B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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+17703009725
Emailinfo.america@elekta.com
Phone+17703009725
Emailinfo.america@elekta.com
Phone+17703009725
Emailinfo.america@elekta.com
Phone+17703009725
Emailinfo.america@elekta.com
Phone+17703009725
Emailinfo.america@elekta.com
Phone+17703009725
Emailinfo.america@elekta.com
Phone+17703009725
Emailinfo.america@elekta.com
Phone+17703009725
Emailinfo.america@elekta.com
Phone+17703009725
Emailinfo.america@elekta.com
Phone+17703009725
Emailinfo.america@elekta.com
Phone+17703009725
Emailinfo.america@elekta.com
Phone+17703009725
Emailinfo.america@elekta.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108717213057227 [Primary]
GS108717213057258 [Package]
Contains: 08717213057227
Package: [5 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 Date2024-07-15
Device Publish Date2024-07-05

On-Brand Devices [Smit Sleeve]

08717213057258Smit Sleeve CT/MR, 4mm
08717213057203Sleeve CT/MR Intrauterine Tube

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