FDA.reportPublic FDA data

SharpSafety

Primary DI
20884521018294
Brand
SharpSafety
Company
Cardinal Health, Inc.
Model
89671
Catalog number
89671
Device description
Sharps Container,Horizontal Drop, Transparent Red
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, hypodermic, single lumen
MMKContainer, Sharps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
MMKContainer, SharpsGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943485000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943485000MONOJECT HORIZONTAL ENTRY SHARPS CONTAINERSherwood Medical Co.1994-09-09FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521018294PackageGS120In Commercial Distribution
40884521018298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452101829420884521018294
4088452101829840884521018298

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2Gallon

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521012301Monoject118030077711803007772016-09-24
10884521018266Monoject897089702016-09-24
10884521022782SharpSafety8512018512012016-09-24
10884521023253Monoject8506SA8506SA2016-09-24
10884521023369Monoject85221R85221R2016-09-24
10884521023482SharpSafety8534SA8534SA2016-09-24
10884521050310Argyle888856080588885608052016-10-06
10884521050747Argyle888856101988885610192016-09-24
10884521050754Argyle888856102788885610272016-09-24
10884521050761Argyle888856103588885610352016-09-24
10884521050778Argyle888856104388885610432016-09-24
10884521050785Argyle888856105088885610502016-09-24
10884521050792Argyle888856106888885610682016-09-24
10884521050808Argyle888856107688885610762016-10-06
10884521050815Argyle888857050788885705072016-09-24
10884521050822Argyle888857051588885705152016-09-24
10884521050839Argyle888857052388885705232016-09-24
10884521050846Argyle888857054988885705492016-09-24
10884521050853Argyle888857055688885705562016-09-24
10884521050877Argyle888857057288885705722016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253004205MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004410MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004540MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004588MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004625SharpSafetyCardinal Health 200, LLCMMK2026-07-13
10192253004885MonojectCardinal Health 200, LLCMMK2026-07-13
10192253005127MonojectCardinal Health 200, LLCFMI2026-07-13
10192253005509MonojectCardinal Health 200, LLCFMI2026-07-13
00810011730809huahongTianjin Huahong Technology Co., Ltd.FMI2026-07-10
00810011730816QikDiagTianjin Huahong Technology Co., Ltd.FMI2026-07-10
00827989008250SharpSafetyHealth Care Logistics, Inc.MMK2026-07-10
10192253004649MonojectCardinal Health 200, LLCMMK2026-07-09
10192253004656MonojectCardinal Health 200, LLCMMK2026-07-09
10192253004663MonojectCardinal Health 200, LLCMMK2026-07-09
10192253004700MonojectCardinal Health 200, LLCMMK2026-07-09
16972857297784Easydrip Glider5 Classic Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
16972857297791Easydrip PentaGlider Plus Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
20192253036982MonojectCardinal Health 200, LLCFMI2026-07-09
20192253036999MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037026MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037033MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037040MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037064MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037071MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037088MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037101MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037125MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037132MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037156MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037194MonojectCardinal Health 200, LLCFMI2026-07-09