FDA.reportPublic FDA data

Medegen Medical products

Primary DI
H362182TY0
Brand
Medegen Medical products
Company
MEDEGEN MEDICAL PRODUCTS, LLC
Model
182TY
Catalog number
182TY
Device description
Sharps: 6.2 Qt. Btl Translucent Yellow
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K942054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942054000SHARPS-TAINERWinfield Industries1994-08-23FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H362182TY2PackageHIBCC12In Commercial Distribution
H362182TY0PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
+1901-867-2951Marshall.bradley@Medegenmed.com

Regulatory Flags#

DUNS number
055527753
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00700812001201Medegen MedicalH140-01H140-012020-05-18
00700812001218Medegen Medical ProductsH140CR-01H140CR-012020-05-18
00700812001225Medegen Medical ProductsH140D-01H140D-012020-05-18
00700812001232Medegen Medical ProductsH141-01H141-012020-05-18
00700812001263Medegen Medical Products, LLCH149-012020-12-20
00700812003892Medegen Medical Products, LLC25652020-12-20
H3621580Medegen Medical products1581582016-09-23
H362158TY0Medegen Medical products158TY158TY2016-09-23
H362158V0Medegen Medical products158V158V2016-09-23
H3621780Medegen Medical products1781782016-09-23
H362178TY0Medegen Medical products178TY178TY2016-09-23
H362178V0Medegen Medical products178V178V2016-09-23
H3621800Medegen Medical products1801802016-09-23
H362180S0Medegen Medical products180S180S2016-09-23
H362180TY0Medegen Medical products180TY180TY2016-09-23
H362180V0Medegen Medical products180V180V2016-09-23
H3621820Medegen Medical products1821822016-09-23
H362182S0Medegen Medical products182S182S2016-09-23
H362182V0Medegen Medical products182V182V2016-09-23
H3621840Medegen Medical products1841842016-09-23

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