FDA.reportPublic FDA data

SPLINT, BUCK'S TRAC, CONVOLUTED, SIZE S

Primary DI
00842430114359
Brand
SPLINT, BUCK'S TRAC, CONVOLUTED, SIZE S
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
371S
Catalog number
371S
Published
2021-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSPSplint, Traction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSPSplint, TractionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430114359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430114359008424301143598424301143590842430114359

GMDN Terms#

Term, Definition table
TermDefinition
Traction bootAn orthopaedic device designed as an open boot that is attached and tightly secured with laces or straps to the foot or both feet of the patient so that traction can be applied to the patient's body. It is typically used during an orthopaedic surgical trauma intervention when traction is being applied to a patient's leg or legs when broken leg bones are being drawn apart, repositioned, and set to the correct position, or in conjunction with a traction table for the application of traction to the patient's spine. It is available in various foot sizes and has a solid sole construction that can be securely attached/locked to other components of the table. 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
06975675781490PrepEM WildEMSRUN GROUPHSP2025-11-07
06975675788864Rhino RescueEMSRUN GROUPHSP2025-11-06
06975675788871Rhino RescueEMSRUN GROUPHSP2025-11-06
06975675788888Rhino RescueEMSRUN GROUPHSP2025-11-06
06975675788857Rhino RescueEMSRUN GROUPHSP2025-10-30
06975675788185Rhino RescueEMSRUN GROUPHSP2025-10-29
06975675788192Rhino RescueEMSRUN GROUPHSP2025-10-29
06975675788208Rhino RescueEMSRUN GROUPHSP2025-10-29
06974567745909RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2024-05-13
16974567745906RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2024-05-13
06974567746937RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-06-28
16974567746934RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-06-28
05060483570051Prometheus Traction Splint SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDHSP2023-05-01
16952534421022SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421039SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421046SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421053SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421060SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421114SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421121SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421138SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421145SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421152SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421169SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
36974567747812RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
36974567747829RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
46974567747819RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
06974567747811RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
06974567747828RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
06974567748092RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-03