FDA.report

Leipzig Applicator

Primary DI
08717213009202
Brand
Leipzig Applicator
Company
Nucletron B.V.
Model
085042-02
Device description
Leipzig Applicator, Ø 20 mm, horizontal
Published
2019-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JAQSystem, applicator, radionuclide, remote-controlled

Product Code Classifications

CodeDeviceSpecialtyClass
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08717213009202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717213009202087172130092028717213009202

GMDN Terms

TermDefinition
General-purpose brachytherapy system applicator, remote-afterloadingA general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area. This device includes a variety of applicators (e.g., hollow needle, tube, catheter), and their associated components [e.g., introducer sheath, guidewire].

Device Sizes

TypeValueUnit
Outer Diameter20Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(770)300-9725info.america@elekta.com

Regulatory Flags

DUNS number
415269930
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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08717213057258Smit Sleeve129117-002024-07-05
08717213054363Luneray110560-012022-11-15
08717213054370Luneray110561-012022-11-15
08717213054387Luneray110562-012022-11-15
08717213054394Luneray110563-012022-11-07
08717213057760Esteya187001SE2022-08-16
08717213056947NA189714P01-032022-06-30
08717213008991X-ray Catheters084880-002016-09-10
08717213009387X-ray Catheters085075-012016-09-10
08717213010192X-ray Catheters089082-012016-09-10
08717213010208X-ray Catheters089083-012016-09-10
08717213010253X-ray Catheters089089-012016-09-10
08717213010260X-ray Catheters089090-012016-09-10
08717213011120X-ray Catheters089420-012016-09-10
08717213014398X-ray Catheters101065-022016-09-10
08717213020474X-ray Catheters189850-002016-09-10
08717213020481X-ray Catheters189851-002016-09-10

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00816389028968Guided Aarhus vaginal template 60 degrees, ø 36 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00816389028975Guide tube collector for up to 7 needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
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00810563022995Ovoid pair, mini ø 16 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-22
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00810563023015Ovoid mini Ø16 mm RightVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-22
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00816389027985Interstitial ovoid pair for 25mm spread, with fixation for guide tubesVarian Medical Systems Deutschland GmbHJAQ2025-05-21
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