FDA UDI
In Commercial Distribution
🇺🇸 United States
Silverstream OTC
DI: 07290019690092
·
Model: SS-1000-02
·
SilverStream Medical Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Silverstream OTC
- Primary DI
- 07290019690092
- Version / Model
- SS-1000-02
- Catalog Number
- FBS-01-1-OSS-1000-02
- Company Name
- SilverStream Medical Ltd.
- Labeler DUNS
- 533346805
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-19
- Public Version
- 1
- Public Version Date
- 2024-05-27
- Public Version Status
- New
- Public Device Record Key
- 3fac8bc3-2163-4ca6-ae70-a0356c2de9cf
Device Description
SilverStream OTC 100ml: SilverStream® OTC is a hypertonic buffered solution, with hydrogel properties, for skin wounds and burns management and maintenance of moisture level.
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59523 | Antimicrobial wound irrigation solution | A solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290019690099 | GS1 | Carton | 24 | In Commercial Distribution | |
| Primary | 07290019690092 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093227 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 100 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temp
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight