FDA.reportPublic FDA data

Isolyser/SMS

Primary DI
10858629005022
Brand
Isolyser/SMS
Company
WCM WASTE & COMPLIANCE MANAGEMENT INC
Model
SMS4000
Catalog number
SMS4000
Device description
5.97 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
Rx
false
OTC
true
Sterile
false
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
10858629005022PackageGS14In Commercial Distribution
00858629005025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085862900502210858629005022
00858629005025008586290050258586290050250858629005025

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

Regulatory Flags#

DUNS number
135942121
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
00858629005001Isolyser/SMSSRS800SRS8002016-09-12
00858629005018Isolyser/SMSSMS2400SMS24002016-09-12
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
10858629005039Isolyser/SMSSMS10000SMS100002016-09-12
20858629005043Isolyser/SMSmSMSm2400SMSm24002016-09-12
10858629005060Isolyser/SMSmSMSm10000SMSm100002016-09-12

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Primary DI, Brand, Company table
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