Isolyser/SMS

Primary DI
00858629005018
Brand
Isolyser/SMS
Company
WCM WASTE & COMPLIANCE MANAGEMENT INC
Model
SMS2400
Catalog number
SMS2400
Device description
3.3 liters sharps container pre-filled with a liquid monomer. Simply fill with sharps (needles, blades, endo files, empty carpules and any other potential sharps), when full, the ‘catalyst’ packs are added causing the liquid to heat and convert into solid plastic polymer, safely encapsulating and rendering the sharps unusable and non-recognizable; making them safe for the regular trash, if acceptable under state and local regulations.
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
K090156000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090156000ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000Wcm Waste & Compliance Management, Inc.2009-09-01FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858629005015PackageGS16In Commercial Distribution
00858629005018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085862900501510858629005015
00858629005018008586290050188586290050180858629005018

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.

Regulatory Flags#

DUNS number
135942121
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858629005001Isolyser/SMSSRS800SRS8002016-09-12
00858629005025Isolyser/SMSSMS4000SMS40002016-09-12
00858629005032Isolyser/SMSSMS10000SMS100002016-09-12
00858629005049Isolyser/SMSmSMSm2400SMSm24002016-09-12
00858629005063Isolyser/SMSmSMSm10000SMSm100002016-09-12
00858629005056Isolyser/SMSmSMSm4000SMSm40002016-09-12
20858629005005Isolyser/SMSSRS800SRS8002016-09-12
10858629005015Isolyser/SMSSMS2400SMS24002016-09-12
10858629005022Isolyser/SMSSMS4000SMS40002016-09-12
10858629005039Isolyser/SMSSMS10000SMS100002016-09-12
20858629005043Isolyser/SMSmSMSm2400SMSm24002016-09-12
10858629005060Isolyser/SMSmSMSm10000SMSm100002016-09-12

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