AccessGUDID - DEVICE: MicroSelectron Digital (08717213034143)

GUDID

Device Identifier (DI) Information

Brand Name: MicroSelectron Digital
Version or Model: 111095-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nucletron B.V.

Primary DI Number: 08717213034143
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 415269930 *Terms of Use

Device Description: Source Position Simulator for microSelectron

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38300	Remote-afterloading brachytherapy system	An assembly of devices using a remotely-controlled radioactive source transport system designed to deliver a therapeutic or palliative radiation dose from a single source or source train to an anatomical region by placing the radioactive source(s) temporarily on or in the treatment site. A standard system consists of 1) a single radioactive source or source train in various forms; 2) a shielded vault to hold the sources when not used; 3) guide tubes/catheters to remotely direct the sources to the treatment site; 4) a remote-controlled mechanism to move the sources inside the guide tubes/catheters; 5) applicators; 6) computer treatment planning programs; and 7) an operator's console.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAQ	System, applicator, radionuclide, remote-controlled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0ed22876-6160-40f0-b179-0fb10f141639
Public Version Date: July 16, 2018
Public Version Number: 1
DI Record Publish Date: June 14, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(770)300-9725
Email: info.america@elekta.com

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