FDA.reportPublic FDA data

Plasti-Products

Primary DI
10797876147089
Brand
Plasti-Products
Company
PLASTI-PRODUCTS INC
Model
147008
Device description
Sharps Container, Red 8qt, Open-Drop
Published
2022-10-31
Public version status
Update
Distribution status
Not 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
K970383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970383000SHARPS CONTAINERCustom Medical Plastics, Inc.1997-07-03FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10797876147089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1079787614708910797876147089

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
18005275396chowarth@plastiproducts.com

Regulatory Flags#

DUNS number
153880372
Device count
1
Lot or batch
true
No natural rubber latex
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
10797876102859Plasti-Products1002852016-04-15
10797876104341Plasti-Products1004342016-04-15
10797876141025Plasti-Products1410202016-04-15
40797876141545Plasti-Products1431542016-04-15
40797876142023Plasti-Products1420202016-04-15
40797876142542Plasti-Products1432542016-04-15
40797876143013Plasti-Products1430202017-01-20

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