FDA.reportPublic FDA data

Curaplex

Primary DI
00815277022002
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
683921OD
Device description
Curaplex Self Care Max Olive Drab
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MCYWound dressing kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCYWound Dressing KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277022002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277022002008152770220028152770220020815277022002

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, single-useA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199972000085Curaplex8600-015358600-015352026-01-23
00199972000092Curaplex8600-015368600-015362026-01-23
00199972000108Curaplex8600-015378600-015372026-01-23
00199972000115Curaplex8600-015388600-015382026-01-23
00199972000122Curaplex8600-015398600-015392026-01-23
00199972000139Curaplex8600-015408600-015402026-01-23
00199972000146Curaplex8600-015418600-015412026-01-23
00199972000153Curaplex8600-015428600-015422026-01-23
00199972000160Curaplex8600-015438600-015432026-01-23
00199972000177Curaplex8600-015448600-015442026-01-23
00199972000184Curaplex8600-015458600-015452026-01-23
00199972000191Curaplex8600-015468600-015462026-01-23
00199972000207Curaplex8600-01546B8600-01546B2026-01-23
00199972000214Curaplex8600-015478600-015472026-01-23
00199972000221Curaplex8600-015488600-015482026-01-23
00199972000238Curaplex8600-015498600-015492026-01-23
00199972000016Curaplex Advanced Hemostatic Gauze4in x 4in (10cm x 10cm)CAHG-4X42025-12-17
00199972000030Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-12-17
00199972000054Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-12-17
00199972000078Curaplex®8600-015558600-015552025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40198459428624MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
40198459433475MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
10661392000831LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392007946LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392007953LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392007960LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392007977LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392008622LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392053691LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392000787LSL HEALTHCARELSL Industries, LLCMCY2025-05-15
40198459171780Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-11-24
00653160381511MEDLINEMEDLINE INDUSTRIES, INC.MCY2024-10-28
40198459057930Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-10-20
40195327657834Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
40195327667925Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
40198459053840Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-06-30
00850003042404carePACExtremity CareMCY2024-02-06
10850003042418carePACExtremity CareMCY2024-02-06
10850003042425carePACExtremity CareMCY2024-02-06
10850003042432carePACExtremity CareMCY2024-02-06
10850003042449carePACExtremity CareMCY2024-02-06
10850003042456carePACExtremity CareMCY2024-02-06
00850003042466carePACExtremity CareMCY2024-02-06
20850003042477carePACExtremity CareMCY2024-02-06
05060418833565Susol® Wound Debridement Pack (Pack of 10)BAILEY INSTRUMENTS LTDMCY2024-01-23
05060418835996Susol® Ulcer Debridement Pack USA (Pack of 10)BAILEY INSTRUMENTS LTDMCY2024-01-23
05060418836726Susol® Ulcer Debridement Pack (Pack of 10)BAILEY INSTRUMENTS LTDMCY2024-01-23
40195327559183Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-12-21
00850050570097Wound CareKitMirodx, LLCMCY2023-11-06
00850050570103Wound CareKitMirodx, LLCMCY2023-11-06