FDA.reportPublic FDA data

Isolyser/SMSm

Primary DI
20858629005043
Brand
Isolyser/SMSm
Company
WCM WASTE & COMPLIANCE MANAGEMENT INC
Model
SMSm2400
Catalog number
SMSm2400
Device description
3.3 liters sharps container in a convenient mail-back package.
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
MMKContainer, Sharps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMKContainer, SharpsGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090157000ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5.Wcm Waste & Compliance Management, Inc.2009-05-04MMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858629005046PackageGS12In Commercial Distribution
20858629005043PackageGS13In Commercial Distribution
00858629005049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085862900504610858629005046
2085862900504320858629005043
00858629005049008586290050498586290050490858629005049

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
10858629005022Isolyser/SMSSMS4000SMS40002016-09-12
10858629005039Isolyser/SMSSMS10000SMS100002016-09-12
10858629005060Isolyser/SMSmSMSm10000SMSm100002016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253004489SharpSafetyCardinal Health 200, LLCMMK2026-09-24
10192253004502MonojectCardinal Health 200, LLCMMK2026-09-24
10192253004557MonojectCardinal Health 200, LLCMMK2026-09-24
10192253004571MonojectCardinal Health 200, LLCMMK2026-09-24
10192253004632SharpSafetyCardinal Health 200, LLCMMK2026-09-24
10192253005080MonojectCardinal Health 200, LLCMMK2026-09-24
10192253005493MonojectCardinal Health 200, LLCMMK2026-09-24
10192253004243MonojectCardinal Health 200, LLCMMK2026-08-03
10192253004250MonojectCardinal Health 200, LLCMMK2026-08-03
10192253004304MonojectCardinal Health 200, LLCMMK2026-08-03
10192253004458MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004465MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004472MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004915MonojectCardinal Health 200, LLCMMK2026-07-31
10192253005295MonojectCardinal Health 200, LLCMMK2026-07-31
10192253005622MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004205MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004410MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004540MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004588MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004625SharpSafetyCardinal Health 200, LLCMMK2026-07-13
10192253004885MonojectCardinal Health 200, LLCMMK2026-07-13
00827989008250SharpSafetyHealth Care Logistics, Inc.MMK2026-07-10
10192253004649MonojectCardinal Health 200, LLCMMK2026-07-09
10192253004656MonojectCardinal Health 200, LLCMMK2026-07-09
10192253004663MonojectCardinal Health 200, LLCMMK2026-07-09
10192253004700MonojectCardinal Health 200, LLCMMK2026-07-09
MHC18601502EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
MHC18601552EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
MHC18602502EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23