FDA.reportPublic FDA data

BUCKS TRACTION w/LINER

Primary DI
10609271080604
Brand
BUCKS TRACTION w/LINER
Company
DARCO INTERNATIONAL, INC.
Model
872-0012-10
Catalog number
872-0012-10
Device description
Universal
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
10609271080604PackageGS14In Commercial Distribution
20609271080601PackageGS112In Commercial Distribution
00609271080607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927108060410609271080604
2060927108060120609271080601
00609271080607006092710806076092710806070609271080607

GMDN Terms#

Term, Definition table
TermDefinition
Lower-limb orthosis ankle/foot componentA non-powered prefabricated (non-customized) component of an externally applied and wearable lower-limb appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct deformities/injuries (e.g., paralysis) or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It is intended to provide motion control functionality through a media-free mechanical resistance mechanism [i.e., spring-actuation with no fluid or gas operating media]. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184231298
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20609271989607Aircore™ InsoleACIP0602026-01-07
20609271989614Aircore™ InsoleACIP0702026-01-07
20609271989621Aircore™ InsoleACIP0752026-01-07
20609271989638Aircore™ InsoleACIP0802026-01-07
00609271989641Aircore™ InsoleACIP0852026-01-07
20609271989652Aircore™ InsoleACIP0902026-01-07
20609271989669Aircore™ InsoleACIP0952026-01-07
20609271989676Aircore™ InsoleACIP1002026-01-07
20609271989683Aircore™ InsoleACIP1052026-01-07
20609271989690Aircore™ InsoleACIP1102026-01-07
20609271989706Aircore™ InsoleACIP1152026-01-07
20609271989713Aircore™ InsoleACIP1202026-01-07
20609271989720Aircore™ InsoleACIP1252026-01-07
20609271989737Aircore™ InsoleACIP1302026-01-07
20609271989744Aircore™ InsoleACIP1352026-01-07
20609271989751Aircore™ InsoleACIP1452026-01-07
20609271989768Aircore™ InsoleACIP1552026-01-07
00609271120167POGO™ PulsusPGP060NPGP060N2025-04-15
00609271120174POGO™ PulsusPGP070NPGP070N2025-04-15
00609271120181POGO™ PulsusPGP075NPGP075N2025-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
16974567748099RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-03
26974567748133RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-27
26974567748140RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-27
26974567748157RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-27
26974567748164RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-27
06974567748139RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-20
06974567748146RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-20
06974567748153RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-20
06974567748160RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-20
06971642800034RTMEDShandong Haidike Medical Products Co., Ltd.HSP2022-12-07
06971642800072RTMEDShandong Haidike Medical Products Co., Ltd.HSP2022-12-07