FDA.reportPublic FDA data

Assure® SD Sharps Container

Primary DI
10015482245013
Brand
Assure® SD Sharps Container
Company
ARKRAY USA, INC.
Model
245001
Device description
Sharps Container for disposal of e.g. needles and syringes (5 Qt. H Lid Red)
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
K130281000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130281000OAK RIDGE PRODUCTS SHARP CONTAINEROak Ridge Products, LLC2013-06-21MMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10015482245013PackageGS120In Commercial Distribution
00015482245016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001548224501310015482245013
00015482245016000154822450160154822450160015482245016

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)818-8877xxx@xxx.xxx

Regulatory Flags#

DUNS number
008171162
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
00015482000011ARK Care®Version 2.5.3.2016-09-23
00015482100025Assure® Slide Pill Swallowing Aid forte10000022018-12-28
00015482100032Assure® Slide Pill Swallowing Aid zero10000032018-12-28
00015482102913ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
00015482102951ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
00015482104658AUTION MAX™ AX-4060 Analyzer1005262025-11-07
00015482129743AUTION™ MAX AX-4022 Analyzer1029742017-02-03
00015482230296TechLITE PEN NEEDLES2301292016-09-23
00015482230326TechLITE Pen Needle 4mm x 32g Sample 10's2340322018-02-26
00015482230999TechLITE PEN NEEDLES2309292016-09-23
00015482232290TechLITE PEN NEEDLES2321292016-09-23
00015482232993TechLITE PEN NEEDLES2329292016-09-23
00015482234232TechLITE PLUS PEN NEEDLES2342322024-03-11
00015482234324TechLITE PEN NEEDLES2341322016-09-23
00015482234928TechLITE PEN NEEDLES2349322016-09-23
00015482235314TechLITE PEN NEEDLES2351312019-05-14
00015482235918TechLITE PEN NEEDLES2359312016-09-23
00015482236311TechLITE PEN NEEDLES2361312016-09-23
00015482236328TechLITE PEN NEEDLES2361322016-09-23
00015482238315TechLITE PEN NEEDLES2381312016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253004243MonojectCardinal Health 200, LLCMMK2026-08-03
10192253004250MonojectCardinal Health 200, LLCMMK2026-08-03
10192253004304MonojectCardinal Health 200, LLCMMK2026-08-03
10192253004458MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004465MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004472MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004915MonojectCardinal Health 200, LLCMMK2026-07-31
10192253005295MonojectCardinal Health 200, LLCMMK2026-07-31
10192253005622MonojectCardinal Health 200, LLCMMK2026-07-31
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
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
MHC18601502EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
MHC18601552EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
MHC18602502EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
MHC18602552EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
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