FDA.reportPublic FDA data

MedSource Sharps Dart 24/case

Primary DI
00816703021392
Brand
MedSource Sharps Dart 24/case
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-64250
Device description
Sharps Dart 24/case
Published
2016-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K150333000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150333000MedSource Sharps DartMedsource International, LLC2015-05-08MMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840155411616PackageGS1192In Commercial Distribution
10816703021399PackageGS124In Commercial Distribution
00816703021392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840155411616008401554116168401554116160840155411616
1081670302139910816703021399
00816703021392008167030213928167030213920816703021392

GMDN Terms#

Term, Definition table
TermDefinition
Sharps containerA device designed as a container to allow 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 be incineration.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041674552
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840155408425MedSource BlanketMS-40521Not Applicable2021-07-07
00816703023617MedSource First Aid KitNORTH-349000Not Applicable2021-08-17
00816703023723MedSource BagsNORTH-678805EMNot Applicable2021-08-17
00816703023839MedSource First Aid WalletNORTH-67M08Not Applicable2021-08-25
00816703024034MedSource Packed BagsSH-B1311Not Applicable2021-08-25
00840155404304MedSource Body BagsMS-BOD200Not Applicable2021-07-28
00840155406094MedSource Emergency BlanketMS-B100Not Applicable2021-07-27
00840155406162MedSource Emergency BlanketMS-B200Not Applicable2021-07-27
00816703023853MedSource BagsNORTH-67M09Not Applicable2021-08-25
00816703023860MedSource BagsNORTH-67M10Not Applicable2021-08-25
00816703023938MedSource Packed BagsNORTH-90LGTRAUMNot Applicable2021-08-25
00816703023952MedSource Packed BagsNORTH-90TRAUMAENot Applicable2021-08-25
00816703024058MedSource First Aid KitSH-B1411Not Applicable2021-08-25
00816703024065MedSource Packed BagsSH-B1412Not Applicable2021-08-25
00816703027097MedSource BagsMS-TLS-3-BNot Applicable2021-08-16
00816703029473MedSource BagsMS-33360-RCSNot Applicable2021-08-03
00840155404540MedSource BagsMS-B33655FPNot Applicable2021-07-28
00840155404670MedSource BagsMS-B3362Not Applicable2021-07-28
00840155407411MedSource BagsMS-B3350RNot Applicable2021-07-28
00840155406667MedSource BagsMS-B3309Not Applicable2021-07-27

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