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
20858629005005Isolyser/SMSSRS800SRS8002016-09-12
10858629005015Isolyser/SMSSMS2400SMS24002016-09-12
10858629005022Isolyser/SMSSMS4000SMS40002016-09-12
10858629005039Isolyser/SMSSMS10000SMS100002016-09-12
00858629005056Isolyser/SMSmSMSm4000SMSm40002016-09-12
10858629005060Isolyser/SMSmSMSm10000SMSm100002016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456219416JMUJMU DENTAL, INCMMK2026-03-09
00840456219423JMUJMU DENTAL, INCMMK2026-03-09
00840456219430JMUJMU DENTAL, INCMMK2026-03-09
00840456219447JMUJMU DENTAL, INCMMK2026-03-09
00840456219454JMUJMU DENTAL, INCMMK2026-03-09
00840456219461JMUJMU DENTAL, INCMMK2026-03-09
10197344176595MEDLINEMEDLINE INDUSTRIES, INC.MMK2026-03-04
01850062218184VerifinePromisemed Medical Devices Inc.MMK2025-11-20
01850062218221VerifinePromisemed Medical Devices Inc.MMK2025-11-20
01850062218290VerifinePromisemed Medical Devices Inc.MMK2025-11-20
06973696790378N/ANingbo HSCC Medical Technology Co.,LtdMMK2025-11-18
00850075610020Trademark Plastics, Inc.Trademark Plastics, Inc.MMK2025-08-25
20197344139733CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139740CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
10197344139767CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139771CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139795CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
00197344139814CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139825CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139849CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
00197344139869CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
00850075255047Med-Tech ResourceMed-Tech Resource, LLCMMK2025-06-04
00850075610006Trademark Plastics, Inc. Trademark Plastics, Inc.MMK2025-05-31
10810100050471KBMEDKB Medical (group), Inc.MMK2025-05-21
10810100050488KBMEDKB Medical (group), Inc.MMK2025-05-21
00810132044144HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07
00810132044151HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07
10810132044165HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07
10810132044172HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07
10810132044189HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07