FDA UDI
In Commercial Distribution
🇺🇸 United States
Isolyser/SMSm
DI: 00858629005049
·
Model: SMSm2400
·
WCM WASTE & COMPLIANCE MANAGEMENT INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Isolyser/SMSm
- Primary DI
- 00858629005049
- Version / Model
- SMSm2400
- Catalog Number
- SMSm2400
- Company Name
- WCM WASTE & COMPLIANCE MANAGEMENT INC
- Labeler DUNS
- 135942121
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 4
- Public Version Date
- 2023-08-18
- Public Version Status
- Update
- Public Device Record Key
- bef115f3-4bf4-4e32-9158-6821f49cfcc7
Device Description
3.3 liters sharps container in a convenient mail-back package.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MMK | Container, Sharps | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35429 | Sharps container | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20858629005043 | GS1 | Case | 3 | In Commercial Distribution | |
| Package | 10858629005046 | GS1 | Retail sale unit | 2 | In Commercial Distribution | |
| Primary | 00858629005049 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090157 | 000 |