FDA.reportPublic FDA data

Mindray

Primary DI
06948350529571
Brand
Mindray
Company
Nanjing Mindray Bio-Medical Electronics Co.,Ltd
Model
A53XXU Cassette fixer
Published
2025-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
FQOTable, Operating-Room, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948350529571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948350529571069483505295716948350529571

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420323304
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
06948350528826MindrayV07XXU Wireless hand control2025-09-22
06948350528833MindrayP14XXU Pad for countertraction post2025-09-22
06948350528864MindrayV03CXU Upper back plate2025-09-22
06948350528871MindrayP09LXU Paediatric head ring2025-09-22
06948350528888MindrayP25XXU Universal supine pad2025-09-22
06948350528895MindrayA66XXU Back plate for shoulder operation2025-09-22
06948350528901MindrayP15XXU Struma pad2025-09-22
06948350528918MindrayA35XXU Multi-function clamp2025-09-22
06948350528925MindrayAB6XXU Wrist support2025-09-22
06948350528932MindrayAB3XXU Univ. adaptor for head position2025-09-22
06948350528949MindrayA26XXU Arthroscopic leg holder2025-09-22
06948350528963MindrayP13XXU Ankle protection strap2025-09-22
06948350528970MindrayP28XXU Chest-hipbone pad2025-09-22
06948350528987MindrayP16LXU Horseshoe head ring2025-09-22
06948350528994MindrayA45XXU Mayo instrument tray2025-09-22
06948350529007MindrayA12XXU Anesthesia frame2025-09-22
06948350529014MindrayP34SXU Head ring2025-09-22
06948350529021MindrayA19XXU Wristlet2025-09-22
06948350529045MindrayP38XXU Prone positioner2025-09-22
06948350529052MindrayA23XXU Shank holder,a pair2025-09-22

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