NA

Primary DI
00810050242165
Brand
NA
Company
DOMICO MED-DEVICE, LLC
Model
15
Device description
"KIT, SMALL, ""I"". Includes: 127 - HOLDER, CHILD AP-PA HEAD (00810050240307), 132 – SUPPORT, HEAD/NECK, 6.5” x 10” x 12” (00810050240208), 133 – REST, CERVICAL HEAD (00810050240055), 136 – WEDGE, 2.25” x 8” x 10” (00810050240338), 138 – WEDGE, 3.75” x 8” x 10” (00810050240161), 139 – WEDGE, 7” x 7” x 10” (00810050240345), 169 – RECTANGLE, 3” x 7.5” x 10” (00810050240413)"
Published
2020-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position
IWYHolder, Head, Radiographic
KXJTable, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1
IWYHolder, Head, RadiographicRadiology1
KXJTable, RadiologicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810050242165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050242165008100502421658100502421650810050242165

GMDN Terms#

Term, Definition table
TermDefinition
Radiological general body-part positionerA device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081253414
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050241618NAVMR33PUBB2020-09-24
00810050243483NA90192020-09-24
00810050241120NAVMR38X012020-09-24
00810050242462NA9012-A2020-09-24
00810050242479N/A9012-B2020-09-24
00810050242486NA9012-C2020-09-24
00810050242493N/A9012-D2020-09-24
00810050242509NA9013-A2020-09-24
00810050242516N/A9013-B2020-09-24
00810050242523NA9013-C2020-09-24
00810050242530N/A9013-D2020-09-24
00810050245579NA278092025-12-09
00810050245562NA335572025-09-24
00810050245548NA60012024-12-31
10810050245545NA60012024-12-31
10810050245552NA60022024-12-31
00810050245524NA91252024-06-21
00810050245531NA91262024-06-21
00810050245517NA333722023-12-29
00810050245500NA4-UF2023-10-31

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00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
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