FDA.reportPublic FDA data

Curaplex

Primary DI
00815277028752
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
560502
Catalog number
560502
Device description
Splint Child Fracture-Pak
Published
2018-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OHOFirst aid kit without drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277028752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277028752008152770287528152770287520815277028752

GMDN Terms#

Term, Definition table
TermDefinition
Infectious waste spill kitA set of devices used to clean up spillage of infectious material. It provides equipment and material for an appropriate method for removing the spillage, and includes the proper container for the disposal of the spillage. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812277034875Curaplex8600-013848600-013842019-07-01
00817617020488Curaplex8600-011938600-011932016-12-27
00817617020495Curaplex8600-011948600-011942016-12-27
00817617020501Curaplex8600-011958600-011952016-12-27
00812277036466Curaplex8600-014538600-014532020-12-30
00812277035230Curaplex1840-20142-A1840-20142-A2019-07-01
00815277020275Curaplex1840-201422016-12-14
00810094574765Curaplex301-670249-KIT301-670249-KIT2022-12-08
00810094576950CuraplexSIVSTTCHP-24-KITSIVSTTCHP-24-KIT2024-09-30
00810094576967CuraplexSIVSTGAHP-24-KITSIVSTGAHP-24-KIT2024-09-30
00810094576974CuraplexSIVSTTAHP-24-KITSIVSTTAHP-24-KIT2024-09-30
00810094577049Curaplex1840-012QM1840-012QM2024-09-30
00810094577056Curaplex1840-013QM1840-013QM2024-09-30
00810094577070Curaplex1840-010QM1840-010QM2024-09-30
00810094577087Curaplex1840-011QM1840-011QM2024-09-30
00810094577094Curaplex1840-014QM1840-014QM2024-09-30
00810094575960Curaplex8600-015138600-015132023-06-30
00810094575977Curaplex670268-KIT670268-KIT2023-06-30
00810094575984Curaplex8600-015148600-015142023-06-30
00812277035407Curaplex8600-014088600-014082019-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842209140596NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140602NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140619NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140633NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140640NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140657NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
06942509220593OP - First aid seriesdata:image/svg+xml,%3csvg%20xmlns='http://www.w3.org/2000/Yiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
06942509220609OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
06942509220616OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
06942509220623OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
00850070635226Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635257Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635264Pro Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635288Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635295Response Plus kitNar Medical Depot, LLCOHO2026-10-23
00850070635318Pro Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635356RESPONSE KITNar Medical Depot, LLCOHO2026-10-23
06942509220647OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220708OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220715OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220722OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220890OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509221217OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
M6898723101040Bleeding Control KitSafeguard US Operating, LLCOHO2026-10-22
M68981601030Rant Strategies K9 Trauma KitSafeguard US Operating, LLCOHO2026-10-20
00842209140367NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140374NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140398NAR KitNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140404NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140411NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14