FDA.reportPublic FDA data

PELVIC RECONSTRUCTION KIT CART

Primary DI
00842430113659
Brand
PELVIC RECONSTRUCTION KIT CART
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
5847-07
Catalog number
5847-07
Published
2020-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEATable, Surgical With Orthopedic Accessories, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEATable, Surgical With Orthopedic Accessories, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430113659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430113659008424301136598424301136590842430113659

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic operating table accessory trolleyA cart designed as a framework on wheels with baskets, shelves, hooks and organizers used to store all the traction related accessory devices (e.g., patient supports, perineal post, traction boots, traction tensioners) that are required to put a patient in traction (e.g., the stretching of a broken limb during orthopaedic surgery). This trolley (cart) is used in association with an orthopaedic operating table.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags#

DUNS number
084527241
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842430116261KIT, HANA SSXT MAQUET 1140 VERSION687668762023-01-17
00842430113093KIT, HANA SSXT-HIP ARTHROSCOPY UNIT687468742022-05-19
00842430103155HANA SSXT- AA THA UNIT, MOT, JP RAILS6879-16879-12022-02-14
00842430103162Hana SSXT- AA THA Unit, MOT, EU Rails6879-26879-22022-02-14
00842430111365HANA SSXT- AA THA UNIT REFURB6870R6870R2022-02-11
00842430113086HANA SSXT- AA THA UNIT687068702022-02-11
00842430114236HANA SSXT-HIP ARTHROSCOPY UNIT, LIFEHEALTHCARE IMAGE 777687368732022-02-11
00842430106484ProFx TRACTION BOOT ADAPTOR ASSY6850-276850-272019-04-02
00842430108914PATIENT TRANSFER ASSY6875-7426875-7422019-04-02
00842430106415Hana/ProFx LATERAL PERINEAL POST6850-4006850-4002018-10-17
00842430106989BUTTOCKS STRAP W/ VELCRO6977-7396977-7392018-12-07
00842430109027Avra Smart Hub Powered by BodiTrak2872-102872-102021-06-14
00842430110283AVRA HEAD SECTION 3IN STERIS 3080, 308569403AVH69403AVH2021-06-14
00842430110290AVRA BACK SECTION 3IN STERIS 3080, 308569403AVB69403AVB2021-06-14
00842430110306AVRA FOOT SECTION, 3IN, STERIS 3080, 308569403AVF69403AVF2021-06-14
00842430110641AVRA 3-PC SET 3IN STERIS 3080 308569403AVS69403AVS2021-06-14
00842430111266AVRA WIRELESS TABLET DISPLAY2872-402872-402021-06-14
00842430112553LATERAL SUPPORT PAD ASSEMBLY5338-1005338-1002021-02-01
00842430101663TABLE, ProFx, REFURBISHED6850R6850R2020-09-09
00842430101977TABLE, INSITE, REFURBISHED6844R6844R2020-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842430116735ADANTE ADAPTER, MAI CLARK SOCKETMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2026-03-31
00842430116766 WELL LEG SUPPORT, SHORTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2026-03-31
00840343726720FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726737FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726744FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726751FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726768FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726775FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00842430109294ADANTE SADDLE POSTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109300ADANTE EXTENDED SADDLE POSTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109317ADANTE TRACTION BOOT, SMALL, PAIRMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109324ADANTE TRACTION BOOT, LARGE, PAIRMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109331ADANTE TRACTION BOOT, EX LARGE, PAIRMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430116605Adante Femoral Hook BracketMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430116612Adante Knee Foot SupportMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117008Adante IntelliTouch Hand PendantMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117022Adante Traction Mount, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117039Adante Traction Mount, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117046Adante Pelvic Center BoardMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117053Adante Knee Extension BoardMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117084Adante Knee Mount, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117091Adante Knee Mount, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117107Adante FlexLation Spar, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117114Adante FlexLation Spar, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117121Adante AX Orthopedic Surgical PlatformMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117138Adante Knee Pad Support Mount, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117145Adante Knee Pad Support Mount, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117152Adante Femur LiftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117169Adante Wireless Foot PedalMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117176Adante Supine Perineal PostMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04