FDA.reportPublic FDA data

SLING, KNEE, KODEL

Primary DI
00842430112690
Brand
SLING, KNEE, KODEL
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
334
Catalog number
334
Published
2020-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00842430112690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430112690008424301126908424301126900842430112690

GMDN Terms#

Term, Definition table
TermDefinition
Knee slingA hanging band, typically suspended from an overhanging structure, intended to be used to cradle a knee to support and limit the range of motion of an injured knee/leg during healing. This is a single-use 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