FDA UDI
In Commercial Distribution
🇺🇸 United States
Stratus Pharmaceuticals, Inc.
DI: 00358980960204
·
Model: 960-20
·
Stratus Pharmaceuticals, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Stratus Pharmaceuticals, Inc.
- Primary DI
- 00358980960204
- Version / Model
- 960-20
- Company Name
- Stratus Pharmaceuticals, Inc.
- Labeler DUNS
- 789001641
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-10
- Public Version
- 1
- Public Version Date
- 2025-11-18
- Public Version Status
- New
- Public Device Record Key
- 71999ece-e461-414d-b344-08b21e6bf2cd
Device Description
Sonafine Dressing, wound, drug Topical Emulsion 5gm/20. SonaFine is registered as Dressing Wound Drug werein the drug is a preservative. SonaFine is not promoted as an antibacterial or antimicrobial dressing. It is not promoted to treat infected wounds.
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
- 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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62069 | Skin semi-occlusive dressing, non-antimicrobial | A substance (e.g., gel, ointment) intended to be topically applied to injured/diseased skin to expedite healing and re-epithelialization primarily through semi-occlusive properties which reduce moisture transmission from the skin to the environment by means of a physical barrier; it may also prevent abnormal scar formation and does not include an antimicrobial agent(s). It is intended for home/healthcare facility use to treat open skin wounds and/or conditions such as lacerations, burns, surgical wounds, radiation dermatitis, and inflammation. 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 | 00358980960204 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110172 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 77 Degrees Fahrenheit