FDA.reportPublic FDA data

Mindray

Primary DI
06948350529052
Brand
Mindray
Company
Nanjing Mindray Bio-Medical Electronics Co.,Ltd
Model
A23XXU Shank holder,a pair
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
06948350529052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948350529052069483505290526948350529052

GMDN Terms#

Term, Definition table
TermDefinition
Leg procedure positionerA non-powered, patient-contact, preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure), or during patient transfer to an operating table; it is not intended for application of traction forces. It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. This is a reusable device.

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
06948350529069MindrayP19XXU Prone pillow,full support2025-09-22

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