FDA.reportPublic FDA data

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00787551041668LPK10037 Lateral Positioning KitXODUS MEDICAL, INC.CCX2026-10-19
00787551041675LPK10036 Lateral Positioning KitXODUS MEDICAL, INC.CCX2026-10-19
00787551041682SPK10756 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-10-19
00860003986844GENESIS BI-WING XL GEN 3.0Infinitus Medical Technologies LLCCCX2026-10-15
00860014205507PNEUMA GENESIS BI-WIUNG POSITIONING SYSTEMInfinitus Medical Technologies LLCCCX2026-10-15
09421905187794Adept Medical Lateral Support SingleADEPT MEDICAL LIMITEDCCX2026-10-05
09421905187800Adept Medical Lateral Support PairADEPT MEDICAL LIMITEDCCX2026-10-05
09421905187817Adept Medical Lateral Vacuum BraceADEPT MEDICAL LIMITEDCCX2026-10-05
15060797554775NADavid Scott CompanyCCX2026-09-25
00850047863799SurgiLockMedicalock CorporationCCX2026-09-24
00850047863829SurgiLockMedicalock CorporationCCX2026-09-24
00850047863836CerviLockMedicalock CorporationCCX2026-09-24
00749756401739DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-09-18
00848530109783Oxygen AccessorySunset Healthcare Solutions, Inc.CCX2026-09-09
00787551041637SPK11761 Jackson Table KitXODUS MEDICAL, INC.CCX2026-07-27
00787551041644SPK11773 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-07-27
00787551041651SPK11774 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-07-27
00851440007902Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.CCX2026-07-22
00198953255315NAGE Medical Systems, L.L.C.KXJ2026-07-08
00811836030907TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
00811836030921TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
20811836030215TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
04719879742367Blessing CathayBLESSING CATHAY CORPORATIONIWY2026-06-22
04719879742374Blessing CathayBLESSING CATHAY CORPORATIONIWY2026-06-22
04719879742381Blessing CathayBLESSING CATHAY CORPORATIONIWY2026-06-22
04719879742398Blessing CathayBLESSING CATHAY CORPORATIONIWY2026-06-22
04719879742404Blessing CathayBLESSING CATHAY CORPORATIONIWY2026-06-22
04719879742411Blessing CathayBLESSING CATHAY CORPORATIONIWY2026-06-22
00860014205514TruBlu HDP BootlinersInfinitus Medical Technologies LLCCCX2026-06-05
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05