FDA.reportPublic FDA data

Plasti-Products

Primary DI
20797876145143
Brand
Plasti-Products
Company
PLASTI-PRODUCTS INC
Model
145014
Device description
sharps container, red horizontal entry,14qt
Published
2016-04-15
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

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
20797876145143PackageGS110In Commercial Distribution
10797876145146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2079787614514320797876145143
1079787614514610797876145146

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
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
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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