FDA UDI
In Commercial Distribution
🇺🇸 United States
Altrazeal Transforming Powder Dressing
DI: 00860000495097
·
Model: 11120-1
·
Altrazeal Life Sciences Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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
- Altrazeal Transforming Powder Dressing
- Primary DI
- 00860000495097
- Version / Model
- 11120-1
- Company Name
- Altrazeal Life Sciences Inc.
- Labeler DUNS
- 624087974
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-07
- Public Version
- 1
- Public Version Date
- 2025-08-15
- Public Version Status
- New
- Public Device Record Key
- c34f9cbd-d1c1-43e5-ac0b-0c190e8422b4
Device Description
Altrazeal Transforming Powder Dressing (sterile wound dresing) 0.20g configuration.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | 878.4022 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47764 | Wound hydrogel dressing, non-antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860000495097 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 55 – 86 Degrees Fahrenheit