FDA.reportPublic FDA data

Oak Ridge Products

Primary DI
10865273000020
Brand
Oak Ridge Products
Company
OAKRIDGE PRODUCTS, LLC
Model
0320-1500
Device description
2 Gallon Sharps Container Slide lid - RED
Published
2016-09-22
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

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
10865273000020PackageGS120In Commercial Distribution
00865273000023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086527300002010865273000020
00865273000023008652730000238652730000230865273000023

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111322165
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
00852482006830Oak Ridge Products0105-01002023-09-20
00852482006823Oak Ridge Products0701-58002023-09-20
10852482006837Oak Ridge Products0105-01002023-09-20
00852482006847Oak Ridge Products0401-11002023-09-20
00852482006410Oak Ridge Products0310-150T2016-09-22
00852482006502Oak Ridge Products0319-15002016-09-22
00852482006519Oak Ridge Products0319-150F2016-09-22
00852482006526Oak Ridge Products0330-15002016-09-22
00852482006533Oak Ridge Products0310-16002016-09-23
00852482006557Oak Ridge Products0330-150R2016-09-22
00852482006564Oak Ridge Products0320-150F2016-09-22
00852482006571Oak Ridge Products0311-150F2016-09-22
00852482006588Oak Ridge Products0319-150R2016-09-22
00852482006595Oak Ridge Products0320-150R2016-09-22
00865273000009Oak Ridge Products0322-150R2016-09-22
00865273000016Oak Ridge Products0310-15002016-09-22
00865273000023Oak Ridge Products0320-15002016-09-22
00865273000030Oak Ridge Products0354-150M2016-09-22
00865273000047Oak Ridge Products0354-150H2016-09-22
00865273000054Oak Ridge Products0354-150B2016-09-22

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