FDA.reportPublic FDA data

Trans-Former

Primary DI
00860001700121
Brand
Trans-Former
Company
Reina Imaging
Model
[T][#]-[Z]
Catalog number
Digital Detector Holder
Device description
Device is a holder for digital detectors(DR Panels). It is used to hold digital detectors in place during radiographic exam. It allows for multiple orientations of the DR panel and features wheels for mobility
Published
2019-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IXYHolder, Radiographic Cassette, Wall-Mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXYHolder, Radiographic Cassette, Wall-MountedRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001700121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001700121008600017001218600017001210860001700121

GMDN Terms#

Term, Definition table
TermDefinition
Stationary x-ray gridA component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging or mammography. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" are filled with aluminium (Al) or another x-ray transparent (radiolucent) organic compound. Radiographic grids are placed between the x-ray target (patient) and the x-ray film and are used to absorb scatter radiation, and improve radiographic image contrast. It typically comes in two patterns, linear and crossed. Most are focused to a line in space called a convergent line, but can be used over a variable range called the focal distance.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8153568181treina@reinaimaging.com

Regulatory Flags#

DUNS number
102370137
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001700107Collim-AidCA22023-06-08
00860001700169Stitching Platform with Handles/ Clear Stitching StandCSS[X]; SPH-F2023-06-08
00860001700176Weight Bearing DRP HoldersWDDR[X]2023-06-08
00860001700183Protect-A-GridP[2][X]DR[NG][Y]Premium Grid Encasement 2019-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858340006547Del Medical, Inc.Del Medical, Inc.IXY2026-03-05
00198953043288NAGE Hualun Medical Systems Co., LtdIXY2025-04-22
00198953043295NAGE Hualun Medical Systems Co., LtdIXY2025-04-22
00198953023259NAGE Hualun Medical Systems Co., LtdIXY2025-02-28
00198953023266NAGE Hualun Medical Systems Co., LtdIXY2025-02-28
08800018422502LLD 86 BasicDRTECH CorporationIXY2024-05-08
05999116186119Z-MOTION STANDCONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIXY2023-12-04
08809832900111SU-2100SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900128SU-4500SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900159LSS-1000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900166SU-2000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900173SD-3500SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900180SU-4000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900197SD-6000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900241SD-6000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08800018421307LLD 129 BasicDRTECH CorporationIXY2023-11-03
08800018421406LLD 129 without rotationDRTECH CorporationIXY2023-11-03
08800018421208DBS-57MDRTECH CorporationIXY2023-09-04
05999116100580WS99(N) WALL STANDCONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIXY2023-08-15
05055449402958KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2023-07-11
05055449415927KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2023-07-11
00858340006387Del Medical, Inc.Del Medical, Inc.IXY2023-05-16
08800018421000LLD 129 CompactDRTECH CorporationIXY2023-04-12
08800018421109LLD 129 SamsungDRTECH CorporationIXY2023-04-12
07350011170111! Mobile wallstandSolutions For Tomorrow ABIXY2023-03-09
B884SFS100L0FS 100 WallstandPausch, L.L.C.IXY2022-12-28
B884SFS100R0FS 100 WallstandPausch, L.L.C.IXY2022-12-28
05055449415705KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2022-12-08
05055449415910KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2022-12-08
05055449415934KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2022-12-08