FDA UDI
In Commercial Distribution
🇺🇸 United States
Phoenix Wound Matrix
DI: 00852513007010
·
Model: FG-0001
·
NANOFIBER SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Phoenix Wound Matrix
- Primary DI
- 00852513007010
- Version / Model
- FG-0001
- Company Name
- NANOFIBER SOLUTIONS, INC.
- Labeler DUNS
- 830384223
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-11
- Public Version
- 4
- Public Version Date
- 2021-08-09
- Public Version Status
- Update
- Public Device Record Key
- 332b7e7b-34a4-4fde-a914-92308aa1cb2b
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
- 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 |
|---|---|---|---|---|
| 62184 | Synthetic nanofiber barrier dressing | A sterile covering made of porous, non-woven, synthetic nanofiber material intended to provide protection and/or promote healing of acute and chronic skin wounds. It is a thin, synthetic polymer (e.g., polycaprolactone) fabric material intended to adhere to the wound (without adhesive) to form a barrier against contamination (e.g., from dirt, water, bacteria) while allowing air to contact the wound; it may be semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) and provides minimal wound exudate absorbency. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852513007010 | GS1 | ||||
| Package | 10852513007017 | GS1 | Shelf Box | 5 | Not in Commercial Distribution | 2019-08-22 |
| Package | 20852513007014 | GS1 | Case | 8 | Not in Commercial Distribution | 2019-08-22 |
| Package | 30852513007011 | GS1 | Shelf Box | 1 | In Commercial Distribution | |
| Package | 40852513007018 | GS1 | Case | 5 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 4 | Inch | |
| Length | 8 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 30 Degrees Celsius