FDA.reportPublic FDA data

Plasti-Products

Primary DI
10797876102859
Brand
Plasti-Products
Company
PLASTI-PRODUCTS INC
Model
100285
Device description
sharps container, red vertical entry,8qt
Published
2016-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970398000SHARPS CONTAINERCustom Medical Plastics, Inc.1997-07-03FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40797876102850PackageGS120In Commercial Distribution
10797876102859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4079787610285040797876102850
1079787610285910797876102859

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-527-5396kandyo@plastiproducts.com

Regulatory Flags#

DUNS number
153880372
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10797876102361Plasti-Products1002362016-04-15
10797876141544Plasti-Products1431542016-04-15
10797876142022Plasti-Products1420202016-04-15
10797876142541Plasti-Products1432542016-04-15
10797876143012Plasti-Products1430202017-01-20
10797876143548Plasti-Products1433542017-01-20
10797876145047Plasti-Products1450042016-04-15
10797876145085Plasti-Products1450082016-04-15
10797876145146Plasti-Products1450142016-04-15
10797876145245Plasti-Products1452042023-06-14
10797876146082Plasti-Products1460082016-04-15
10797876146143Plasti-Products1460142016-04-15
40797876102362Plasti-Products1002362016-04-15
10797876104341Plasti-Products1004342016-04-15
10797876141025Plasti-Products1410202016-04-15
40797876141545Plasti-Products1431542016-04-15
40797876142023Plasti-Products1420202016-04-15
40797876142542Plasti-Products1432542016-04-15
40797876143013Plasti-Products1430202017-01-20
40797876143549Plasti-Products1433542017-01-20

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