FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen Cycle
DI: 00850012210061
·
Model: SL290
·
STERILUCENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen Cycle
- Primary DI
- 00850012210061
- Version / Model
- SL290
- Catalog Number
- SL290
- Company Name
- STERILUCENT, INC.
- Labeler DUNS
- 005634969
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-04-29
- Public Version
- 1
- Public Version Date
- 2020-05-07
- Public Version Status
- New
- Public Device Record Key
- f2ca66ef-0e11-442e-93ac-aa833f418ece
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13732 | Biological sterilization indicator | A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850012210054 | GS1 | ||||
| Primary | 00850012210061 | GS1 |
Customer Contacts
- Phone
- 1-877-721-8405
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192001 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 60 – 100 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store in direct sunlight or any other form of UV light.
- Type
- Special Storage Condition, Specify
- Special Conditions
- • Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages