FDA.reportPublic FDA data

NA

Primary DI
00810050244299
Brand
NA
Company
DOMICO MED-DEVICE, LLC
Model
33516
Device description
FLEX FRAME. Includes: 33528 - FLEX FRAME PATIENT PADS (10810050244203), 33529 - FLEX FRAME SECUREMENT STRAP SET (00810050244268), 33531 - FLEX FRAME CRANK HANDLE (00810050244275)
Published
2021-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KXJTable, Radiologic

Product Code Classifications

CodeDeviceSpecialtyClass
KXJTable, RadiologicRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810050244299PackageGS11In Commercial Distribution
00810050244282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050244299008100502442998100502442990810050244299
00810050244282008100502442828100502442820810050244282

GMDN Terms

TermDefinition
Spinal surgery positioning boardA device comprised of a supportive foundation and adjustable positioning elements designed to be attached to an operating table to enable correct positioning and immobilization of a patient during surgical procedures involving the spine (e.g., thoracolumbrosacral surgery, disc decompression). It supports the patient in the prone or supine position providing a close approximation to a patient's natural lumbar lordosis while facilitating reduced abdominal compression. It typically consists of a base plate/board made of durable materials (e.g., metal, carbon fibre) to which other devices are attached (e.g., intraoperative positioners, headrest, x-ray cassette). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
081253414
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810050245579NA278092025-12-09
00810050245562NA335572025-09-24
10810050245545NA60012024-12-31
10810050245552NA60022024-12-31
00810050245524NA91252024-06-21
00810050245531NA91262024-06-21
00810050245517NA333722023-12-29
00810050245500NA4-UF2023-10-31
10810050245446NA60002023-10-13
00810050245494NA2822023-10-13
00810050245470NA169-202023-05-01
00810050245487NA2-UF2023-05-01
00810050240840NA1592020-06-11
00810050243148NA128-UF2020-08-12
00810050245289NA1632022-05-27
00810050245302NA142-202022-05-27
00810050245456NA303-UF2022-11-18
00810050245432NA209-202022-11-10
00810050245401NA333502022-10-31
00810050245425NA108-82022-10-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810050245579NADOMICO MED-DEVICE, LLCKXJ2025-12-09
04046768146037Carbon Fiber Table TopMAQUET GmbHKXJ2025-01-27
04046768146044Carbon Fiber Table TopMAQUET GmbHKXJ2025-01-27
04046768146051Carbon Fiber Table TopMAQUET GmbHKXJ2025-01-27
00887761975682Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2025-01-20
00887761975699Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2025-01-20
00857534006721Headboard AssemblyDEERFIELD IMAGING, INC.KXJ2024-10-04
00810050245524NADOMICO MED-DEVICE, LLCKXJ2024-06-21
00810050245531NADOMICO MED-DEVICE, LLCKXJ2024-06-21
00858340006448Del Medical/UniversalDel Medical, Inc.KXJ2024-03-18
00858340006455Del Medical/UniversalDel Medical, Inc.KXJ2024-03-18
00858340006462Del Medical/UniversalDel Medical, Inc.KXJ2024-03-18
05999116126108Z-TABLECONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságKXJ2023-12-04
00810050245500NADOMICO MED-DEVICE, LLCKXJ2023-10-31
00195278629234NAGE Medical Systems (Tianjin) Co., Ltd.KXJ2023-08-04
60889976554104CARESTREAM DR Long Length Imaging StandCARESTREAM HEALTH, INC.KXJ2023-06-26
00810050245470NADOMICO MED-DEVICE, LLCKXJ2023-05-01
10841962119389Insight™QfixKXJ2023-01-24
10841962119396Insight™QfixKXJ2023-01-24
00887761967342Orthopedic ExtensionBaxter Medical Systems GmbH + Co. KGKXJ2023-01-17
00887761973893Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-17
00887761971608Side Rail Adapter & ExtensionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-11
00887761974593TS 7500Baxter Medical Systems GmbH + Co. KGKXJ2023-01-11
00887761968325iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761972841Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761973343Arm-PositioningBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761973350Arm-PositioningBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761967625X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967748Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967793Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03