FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V
DI: 00850012210009
·
Model: HC 80TT-120-001
·
STERILUCENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V
- Primary DI
- 00850012210009
- Version / Model
- HC 80TT-120-001
- Catalog Number
- HC 80TT-120-001
- Company Name
- STERILUCENT, INC.
- Labeler DUNS
- 005634969
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-28
- Public Version
- 1
- Public Version Date
- 2020-05-06
- Public Version Status
- New
- Public Device Record Key
- f88961c0-953f-452c-aaf7-010ac999ee6f
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MLR | Sterilizer, Chemical | General Hospital | 880.6860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40567 | Hydrogen peroxide gas sterilizer | A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using hydrogen peroxide (H2O2) gas with low humidity content as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It includes a treatment chamber where the devices to be sterilized are placed, usually after cleaning of gross debris, and a means to introduce the gas into the chamber; it is not intended to generate a gas plasma. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850012210009 | GS1 |
Customer Contacts
- Phone
- 1-877-721-8405
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190005 | 000 |