AccessGUDID - DEVICE: Esteya (08717213050983)

GUDID

Device Identifier (DI) Information

Brand Name: Esteya
Version or Model: 187124P01-03
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nucletron B.V.

Primary DI Number: 08717213050983
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 415269930 *Terms of Use

Device Description: Surface Applicator, 10mm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
41023	Skin-tumour low-voltage therapeutic x-ray system	An assembly of devices designed to deliver low-voltage x-ray beams used in palliative or curative treatments of superficial skin tumours. Acceleration voltages associated with this kind of x-ray therapy system are usually below 100 kV.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAD	System, therapeutic, x-ray

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132092	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify:
Outer Diameter: 10.0 Millimeter

Device Record Status

Public Device Record Key: 4e7b960f-9856-4664-9bc6-d50f9321627c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 10, 2016

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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