FDA.reportPublic FDA data

Curaplex

Primary DI
00810071635786
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
1860-08705
Catalog number
1860-08705
Device description
Curaplex Sharps Container, 32 Quart 1EA 10EA/CS
Published
2022-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MMKContainer, sharps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMKContainer, SharpsGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942054000SHARPS-TAINERWinfield Industries1994-08-23FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810071635823PackageGS110In Commercial Distribution
00810071635786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071635823008100716358238100716358230810071635823
00810071635786008100716357868100716357860810071635786

GMDN Terms#

Term, Definition table
TermDefinition
Sharps containerA hard-walled container designed for the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level, typically by incineration.

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094575809Curaplex680152-KIT680152-KIT2023-04-30
00815277028059Curaplex8600-ATFMLOK2016-12-14
00815277029377Curaplex680150-KIT680150-KIT2018-12-15
01999720000003Curaplex Advanced Hemostatic Gauze4in x 4in(10cm x 10cm)CAHG-4X42025-11-25
01999720000027Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-11-25
01999720000041Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-11-25
01999720000065Curaplex®8600-015558600-015552025-11-13
01999720000263Curaplex670070-KIT670070-KIT2025-11-25
00810071638619CURAPLEXS1137301-S11372023-03-30
00817617023052Curaplex3141-910103141-910102017-09-04
00817617023069Curaplex3141-910123141-910122017-09-04
00817617023083Curaplex3141-910143141-910142017-09-04
00817617023335Curaplex36111361112017-09-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00768627017275Norco Sharps ContainerNORTH COAST MEDICAL, INC.MMK2026-06-01
10192253005660NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005684NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005691NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005707NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005714NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005721NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005738NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005745NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005752NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005769NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10197344118496MEDLINEMEDLINE INDUSTRIES, INC.MMK2024-11-28
16971292007088AUVONShenzhen Yuwen E-Commerce Co., Ltd.MMK2024-08-13
16971292007095AUVONShenzhen Yuwen E-Commerce Co., Ltd.MMK2024-08-13
10884521023192MonojectCardinal Health 200, LLCMMK2023-12-21
10884521023239MonojectCardinal Health 200, LLCMMK2023-12-21
20884521023113MonojectCardinal Health 200, LLCMMK2023-12-21
16947462492404GongdongZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.MMK2023-09-07
10884521141407SharpSafetyCardinal Health, Inc.MMK2023-08-23
09337363001834BladeFlask EVOQLICKSMART PTY LTDMMK2023-06-23
09337363001841BladeFlask EVOQLICKSMART PTY LTDMMK2023-06-23
10884521023062Sharps-A-GatorCardinal Health, Inc.MMK2023-02-06
10884521023338SharpSafetyCardinal Health, Inc.MMK2023-02-06
20884521076805Sharps-A-GatorCardinal Health, Inc.MMK2023-02-06
10080196282654MedlineMEDLINE INDUSTRIES, INC.MMK2022-11-30
10612479209340McKessonMCKESSON MEDICAL-SURGICAL INC.MMK2022-07-28
10073088161854BEMISBemis de México, S.A. de C.V.MMK2022-04-07
10888277171022MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMK2022-02-18
10888277171107MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMK2022-02-18
10888277171145MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMK2022-02-18