FDA.reportPublic FDA data

Mindray

Primary DI
06948350528833
Brand
Mindray
Company
Nanjing Mindray Bio-Medical Electronics Co.,Ltd
Model
P14XXU Pad for countertraction post
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
06948350528833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948350528833069483505288336948350528833

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient positioning set, reusableA collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent a patient from sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: a base plate/bar that serves as a foundation to which patient positioners are attached, clamps/adaptors, and disposable/reusable padded positioners dedicated to a body part (e.g., non-slip positioning pad, headrest). 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
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
06948350529069MindrayP19XXU Prone pillow,full support2025-09-22

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