FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MIRRAGEN® Advanced Wound Matrix
DI: 00812005030025
·
Model: MET-0101
·
ETS Wound Care LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MIRRAGEN® Advanced Wound Matrix
- Primary DI
- 00812005030025
- Version / Model
- MET-0101
- Company Name
- ETS Wound Care LLC
- Labeler DUNS
- 080578874
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-14
- Public Version
- 10
- Public Version Date
- 2025-02-03
- Public Version Status
- Update
- Public Device Record Key
- b2d30218-764d-46e2-bde5-f526d9a138a3
- Distribution End Date
- 2023-11-29
Device Description
Resorbable Borate Glass Wound Management Device
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
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QSZ | Absorbable Synthetic Wound Dressing | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64853 | Synthetic wound matrix dressing | A sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00812005030056 | GS1 | Box | 10 | Not in Commercial Distribution | 2023-11-29 |
| Primary | 00812005030025 | GS1 |
Customer Contacts
- Phone
- 573-202-2550
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161067 | 000 |