FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sporox ® II
DI: D687751901
·
Model: 75190
·
Sultan Healthcare Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Sporox ® II
- Primary DI
- D687751901
- Version / Model
- 75190
- Company Name
- Sultan Healthcare Inc
- Labeler DUNS
- 056296981
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2017-11-24
- Public Version
- 3
- Public Version Date
- 2021-12-09
- Public Version Status
- Update
- Public Device Record Key
- 113a4711-e192-40da-8eb9-fe90d12bdf0a
- Distribution End Date
- 2021-12-09
Device Description
Sporox® II Sterilizing & Disinfecting Solution, 8 oz bottles, 6 pack
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| MED | Sterilant, medical devices | General Hospital | 880.6885 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44835 | Hydrogen peroxide device sterilant | A gaseous or liquid substance that includes hydrogen peroxide (H2O2) as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. The substance may be presented in discrete quantities to accommodate the requirements of a sterilization device or system. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D687751901 | HIBCC | ||||
| Unit of Use | D687751900 | HIBCC |
Customer Contacts
- Phone
- +1(800)989-8825
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 8 | Fluid Ounce |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in an upright position, in a cool, dry place in areas inaccessible to small children.