FDA.reportPublic FDA data

EMERGENCY CRANK

Primary DI
00842430114885
Brand
EMERGENCY CRANK
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
6977-679
Catalog number
6977-679
Published
2020-09-08
Public version status
Update
Distribution status
Not 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
00842430114885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430114885008424301148858424301148850842430114885

GMDN Terms#

Term, Definition table
TermDefinition
Operating table handcrankA manually-operated mechanical device intended to be used to enable operation and adjustment of an operating table and its associated devices, including table tops, patient positioners, and positioning pads. It may be employed in normal operation or as backup when the electrical system and/or motors of an operating table have failed.

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
00842430112553LATERAL SUPPORT PAD ASSEMBLY5338-1005338-1002021-02-01
00842430101663TABLE, ProFx, REFURBISHED6850R6850R2020-09-09
00842430101977TABLE, INSITE, REFURBISHED6844R6844R2020-09-09
00842430115097SLING, REHAB SHOULDER, ABDUCTION8678672020-09-03
00842430112119IMMOBILIZER, SHOULDER, UNIVESAL,W/ STRAP146S146S2020-07-27
00842430100031Allegro Table Refurbished 120V, 60HZ6800R6800R2016-09-15
00842430104022ALUMINUM SIDE RAIL SOCKET539453942018-04-18
00842430104404PIVOTING ARM BOARD W/TEMPUR 2IN535653562018-04-18
00842430104497CMBU RADIOLUCENT DORO ADAPTER5979-3005979-3002018-05-10
00842430104503CMBU RADIOLUCENT MAYFIELD ADAPTER5979-2005979-2002018-05-10
00842430104541COUPLER II RADIOLUCENT DORO ADAPTER5873-3005873-3002018-04-26
00842430104947Levó Protective Arm Sleeve789278922019-03-08
00842430105098PIVOTING ARM BOARD W/TEMPUR 3IN535753572018-04-18
00842430105159Trios/OTS TRACTION EXTENSION SHORT5855-5785855-5782018-04-24
00842430105166Trios/OTS TRACTION EXTENSION LONG5855-1935855-1932018-04-26
00842430105357GM BOARD LEFT PAD5855-2875855-2872018-05-10
00842430105371GM BOARD RIGHT PAD5855-2865855-2862018-05-10
00842430105739Trios/OTS FOOT-END DRAPE HANGER POST5855-6175855-6172018-05-03
00842430105746Trios/OTS HEAD-END DRAPE HANGER POST5855-6155855-6152018-05-03
00842430105920PIVOTING ARM BOARD ASSY W/OUT PAD5362-65362-62018-11-09

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