FDA.reportPublic FDA data

Grid entity

Primary DI
04260502640197
Brand
Grid entity
Company
PROTEC GmbH & Co. KG
Model
WR
Catalog number
7051-0-0154
Device description
X-ray film cassette holder
Published
2019-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04260502640197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260502640197042605026401974260502640197

GMDN Terms#

Term, Definition table
TermDefinition
X-ray film cassette holderA device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314629130
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
04260502640357PROGNOST XStable top 196,3x65,5cm composite fiber7034-0-00002020-12-15
04260502640203PROGNOST XPtable top 200x65,5cm composite fiber7036-0-17102020-12-15
04260502640210PROGNOST XPtable top 200x75,5cm composite fiber7036-0-17112020-12-15
04260502640227PROGNOST XPtable top 226x75,5cm composite fiber7036-0-17122020-12-15
04260502640234PROGNOST XPtable top 200x75,5cm, carbon fiber7036-0-17132020-12-15
04260502640241PROGNOST XPtable top 226x75,5cm carbon fiber7036-0-17142020-12-15
04260502640258PROGNOST XPEtable top 200x65,5cm composite fiber7037-6-17102020-12-15
04260502640265PROGNOST XPEtable top 200x75,5cm composite fiber7037-6-17112020-12-15
04260502640272PROGNOST XPEtable top 226x75,5cm composite fiber7037-6-17122020-12-15
04260502640289PROGNOST XPEtable top 200x75,5cm, carbon fiber7037-6-17132020-12-15
04260502640296PROGNOST XPEtable top 226x75,5cm carbon fiber7037-6-17142020-12-15
04260502640302PROGNOST XPE-Akkutable top 200x65,5cm composite fiber7038-9-17102020-12-15
04260502640319PROGNOST XPE-Akkutable top 200x75,5cm composite fiber7038-9-17112020-12-15
04260502640326PROGNOST XPE-Akkutable top 226x75,5cm composite fiber7038-9-17122020-12-15
04260502640333PROGNOST XPE-Akkutable top 200x75,5cm, carbon fiber7038-9-17132020-12-15
04260502640340PROGNOST XPE-Akkutable top 226x75,5cm carbon fiber7038-9-17142020-12-15
04260502640043PROGNOST XS7034-0-00002016-10-28
04260502640050PROGNOST XP7036-0-1703L2016-10-28
04260502640067PROGNOST XPE7037-1-1703L2016-10-28
04260502640074PROGNOST XPE-Akku7038-9-1703L2016-10-28

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