FDA UDI
In Commercial Distribution
🇺🇸 United States
STERRAD™
DI: 10705037068432
·
Model: 10104-010
·
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- STERRAD™
- Primary DI
- 10705037068432
- Version / Model
- 10104-010
- Company Name
- ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Labeler DUNS
- 947451626
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-25
- Public Version
- 2
- Public Version Date
- 2025-12-15
- Public Version Status
- Update
- Public Device Record Key
- 737ab1fa-7226-4099-b879-c21e96c4e327
Device Description
STERRAD™ 100NX with ALLClear™ Technology, 2-Door and ULTRA GI cycle
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| 36305 | Plasma sterilizer | A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using vapours (or gases) in plasma state; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris and then packed; a means to introduce the vapour [e.g., hydrogen peroxide (H2O2)] into the chamber; electrodes that are activated to convert the vapour into plasma; a radio-frequency generator; and cycle controls. The device is available in stand-alone (bulk) and tabletop units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705037068432 | GS1 |
Customer Contacts
- Phone
- +1(888)783-7723
- [email protected]