FDA.reportPublic FDA data

NA

Primary DI
00810050245500
Brand
NA
Company
DOMICO MED-DEVICE, LLC
Model
4-UF
Device description
"KIT, SMALL, ""A"". Includes: 112-UF - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050240581), 114-UF - RECTANGLE, 2” x 7.5” x 9.5” (00810050240604), 116-UF - WEDGE, 3” x 4” x 7”, (10810050242919), 117-UF - WEDGE, 2.5” x 7” x 10”, (10810050242940), 118-UF - WEDGE, 7” x 7” x 7” (00810050242394)"
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position
KXJTable, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1
KXJTable, RadiologicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810050245500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050245500008100502455008100502455000810050245500

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
00810050245449NA60002023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00696588008417ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00696588008424ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00696588008431ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00696588008448ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00696588008455ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00198953183380NAGE Medical Systems, L.L.C.KXJ2026-11-03
00198953183434NAGE Medical Systems, L.L.C.KXJ2026-11-03
05060624129049Face Cushy Set (Helmet + Mirror)CARE SURGICAL LIMITEDCCX2026-11-03
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