Bar Code Reader Kit

Primary DI
B365503720
Brand
Bar Code Reader Kit
Company
Aktina Corp.
Model
50-372
Published
2021-05-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K161984000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161984000Interlocked Circular Small Field Collimators, Elekta IntegratedAktina Medical Corporation2016-09-27IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B365503720PrimaryHIBCC0
00810110900417SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810110900417008101109004178101109004170810110900417

GMDN Terms#

Term, Definition table
TermDefinition
Barcode readerA device that reads and interprets barcodes of various format. A barcode is typically an electronically readable information strip consisting of parallel, vertical stripes and spaces of variable thicknesses which can also be presented in two or more layered information levels. This device may have the capability of storing the read data and downloading this into other data systems when this is required.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
787178920
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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B3658080000isoPoint Validation Software80-8002024-07-01
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B365603100Respiratory Belt with Bladder, Small60-3102016-09-28
B365603110Respiratory Belt with Bladder, Medium60-3112016-09-28
B365603120Respiratory Belt with Bladder, Large60-3122016-09-28
B365503710Transport Cart, SRS Cones50-3712021-05-21
B365503750Film Holder50-3752021-05-21
B365503022100Circular Small Field Cone Insert, Elekta, 21mm50-302-2102016-10-04
B365503022200Circular Small Field Cone Insert, Elekta, 22mm50-302-2202016-10-04
B365503022300Circular Small Field Cone Insert, Elekta, 23mm50-302-2302016-10-04
B365503022400Circular Small Field Cone Insert, Elekta, 24mm50-302-2402016-10-04
B365503022500Circular Small Field Cone Insert, Elekta, 25mm50-302-2502016-10-04
B365503022600Circular Small Field Cone Insert, Elekta, 26mm50-302-2602016-10-04
B365503022700Circular Small Field Cone Insert, Elekta, 27mm50-302-2702016-10-04
B365503022800Circular Small Field Cone Insert, Elekta, 28mm50-302-2802016-10-04
B365503022900Circular Small Field Cone Insert, Elekta, 29mm50-302-2902016-10-04
B365503023000Circular Small Field Cone Insert, Elekta, 30mm50-302-3002016-10-04
B365503023100Circular Small Field Cone Insert, Elekta, 31mm50-302-3102016-10-06

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