FDA.reportPublic FDA data

COVER, 5855 ORTHOPEDIC TRAUMA TOP W/O ARC

Primary DI
00842430111136
Brand
COVER, 5855 ORTHOPEDIC TRAUMA TOP W/O ARC
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
5855-3000
Catalog number
5855-3000
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
00842430111136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430111136008424301111368424301111360842430111136

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, reusableA noninvasive flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is not a dedicated handle cover, device cap nor an ultrasound transducer cover. 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