FDA.reportPublic FDA data

RAIL ASSEMBLY, RIGHT, REFURBISHED

Primary DI
00842430104794
Brand
RAIL ASSEMBLY, RIGHT, REFURBISHED
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
6977-501R
Catalog number
6977-501R
Published
2020-10-13
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
00842430104794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430104794008424301047948424301047940842430104794

GMDN Terms#

Term, Definition table
TermDefinition
Torso intraoperative positionerA preformed device (e.g., cushion, foam pad, lateral post, bolster, wedge) designed to be attached to an operating table for stabilizing a patient's body trunk (e.g., chest, pelvis, hips) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures (e.g., orthopaedic surgery). It is typically used when the patient is in the prone or lateral position; components for attachment to the operating table (e.g., adaptors, straps) may be included. This is a reusable device.

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
00842430117312ADANTE DURABLE BODY STRAP, NO HOOK6895-13656895-13652026-04-17
00842430116667ADANTE PELVIC CENTER POSTLESS PAD6895-13066895-13062025-07-04
00842430116735ADANTE ADAPTER, MAI CLARK SOCKET6895-21906895-21902026-03-31
00842430116766 WELL LEG SUPPORT, SHORT5855-838S5855-838S2026-03-31
00842430116742PKIT, STS Trios, LPC, SG ARM PAD5808PC-12026-01-21
00842430116759PKIT PROAXIS LPC SG HIP ARM6988A-PC-12026-01-21
10842430116749PKIT, STS Trios, LPC, SG ARM PAD5808PC-12026-01-21
10842430116756PKIT PROAXIS LPC SG HIP ARM6988A-PC-12026-01-21
00842430101717TABLE, INSITE684468442020-09-09
00842430107450INSITE TABLE, 230V6844i6844i2020-09-09
00842430107467TABLE, ProFx, 230 VOLT6850i6850i2020-09-09
00842430112102TABLE, ProFx685068502020-09-09
00842430114601TABLE, INSITE, 100V6844J6844J2020-09-08
00842430100017Allegro Imaging Table 120V, 60HZ680068002016-09-13
00842430100024Allegro Imaging Table 220-230V, 50/60HZ6800I6800I2016-09-15
00842430109188PRONECONNECT PROTECTIVE HELMETPC501FHPC501FH2025-08-29
00842430109195PRONECONNECT ADJUSTABLE HELMETPC502AHPC502AH2025-08-29
00842430109201PRONECONNECT COMBO PACK 4L, 3M, 3SPC-COMBOPC-COMBO2025-08-29
00842430109218PRONECONNECT LOW PROFILE MIRRORPC520MPC520M2025-08-29
00842430109225PRONECONNECT ADJUSTABLE MIRRORPC590MPC590M2025-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948350529786MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdJEA2025-09-22
06948350529823MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdJEA2025-09-22
00840343726645GEN2SURGIX MEDICAL LLCJEA2025-08-05
04719886909722DA Power HookUNITED ORTHOPEDIC CORP.JEA2025-07-14
04719886909739DA Power HookUNITED ORTHOPEDIC CORP.JEA2025-07-14
04719886909746DA Power HookUNITED ORTHOPEDIC CORP.JEA2025-07-14
04719886909753DA Power HookUNITED ORTHOPEDIC CORP.JEA2025-07-14
04719886909760DA Power HookUNITED ORTHOPEDIC CORP.JEA2025-07-14
04719886905434DA Power HookUNITED ORTHOPEDIC CORP.JEA2025-03-05
04046768146853JoystickMAQUET GmbHJEA2025-01-27
04719886901658DA Power HookUNITED ORTHOPEDIC CORP.JEA2024-12-11
04719886901672DA Power HookUNITED ORTHOPEDIC CORP.JEA2024-12-11
04719886901689DA Power HookUNITED ORTHOPEDIC CORP.JEA2024-12-11
04719886901696DA Power HookUNITED ORTHOPEDIC CORP.JEA2024-12-11
00840343723156FusionMAXSURGIX MEDICAL LLCJEA2024-08-19
00842430113727FOOT SUPPORT ASSEMBLYMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2024-03-06
04250435539521DORO® LUCENT iMRI Interface Adaptor IMRISBlack Forest Medical GmbHJEA2023-10-25
00842430101311SPAR,LEG,RIGHT RADIOLUCENT,REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430101328SPAR, LEG, LEFT, RADIOLUCENT, REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430101335SPAR ASSEMBLY, RIGHT, REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430101342SPAR ASSEMBLY, LEFT, REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430103414UPPER ARM SUPPORT & PAD, REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430105500Trios/OTS Lateral Extension PadMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430106590Radiolucent Leg Spar RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430106613Hana Radiolucent Leg Spar LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430107498Zentrum ZXT System, EUMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430107504Zentrum ZXT System, JPMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430107511Zentrum ZXT System, USMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430108532TRACTION BOOT & PLATE, SMALL, LT & RTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430108549TRACTION BOOT & PLATE, LARGE, LT & RTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19