Calypso Beacon Care Package-Lung

Primary DI
00850011006122
Brand
Calypso Beacon Care Package-Lung
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
2
Catalog number
ASM0341
Published
2019-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170570000Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc.2018-04-06IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011006122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011006122008500110061228500110061220850011006122

GMDN Terms#

Term, Definition table
TermDefinition
Implanted-marker patient positioning systemAn assembly of devices used primarily in radiation therapy applications, for radiation treatment planning, and during therapy treatment to align and monitor a patient's position relative to the isocenter of a radiation therapy system (e.g., a linear accelerator). It detects electromagnetic signals provided by passive implanted markers (transponders) which have been surgically implanted in or near the target site prior to the treatment. This enables accurate positioning and tracking of all information throughout the treatment phase and helps to ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070809675
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810563022001Mandrin for 200 mm lengthGM11010450GM110104502024-02-16
10816389027296Universal fixation button, radiopaque, pack of 100, non-sterileGM11003800GM110038002016-09-23
00810563021967Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrinGM11014710GM110147102024-02-16
00810563021974Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrinGM11014720GM110147202024-02-16
00810563021981Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrinGM11014730GM110147302024-02-16
00810563022018Mandrin for 320 mm lengthGM11010470GM110104702024-02-16
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinGM11014700GM110147002024-02-16
00810563021998Mandrin for 113 mm lengthGM11010390GM110103902024-02-16
00816389022522Mandrin for 200mm length Needle for Plastic Interstitial NeedleGM11003270GM110032702021-02-02
00816389022188Flexible probe, 2.8 mm diameter x 320 mmGM11002280GM110022802016-09-22
00816389022195Mould probe, ø 1.8 diameter x 320 mm, with mandrinGM11002290GM110022902016-09-19
00816389022478Mandrin for 320mm lengthGM11003100GM110031002016-09-23
00816389022553Mandrin for 113mm length NeedleGM11003340GM110033402016-09-22
00816389022935Catheter flap 200 mm x 290 mm x 10 mm, 40 channelsGM11003910GM110039102016-09-23
00816389024243Plastic needle, 2.0 mm diameter, 113 mm length with mandrin for 113 mm needlesGM11007560GM110075602016-09-22
00816389024250Plastic needle 2.0 mm diameter, 200 mm length with mandrin for 200 mm needlesGM11007570GM110075702016-09-18
00816389024267Plastic needle ø 2.0 mm diameter, 320 mm length with mandrin for 320 mm needlesGM11007580GM110075802016-09-19
00816389025615Plastic needle 2.0 mm diameter, 320 mm length, blunt tip w/ mandrinGM11010750GM110107502016-09-22
00854393006084Velocity4.3Velocity 4.32026-07-16
10816389027234Cleaning Cap, dark blue (pack of 25)GM11010770GM110107702016-09-22

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