MIRRAGEN® Advanced Wound Matrix
GUDID B477MWM0202SB1
Resorbable Borate Glass Wound Management Device
ETS WOUND CARE LLC
Cavity-wound management dressing| Primary Device ID | B477MWM0202SB1 |
| NIH Device Record Key | 20ca8fa5-f736-4e00-bf82-8a6ab85299c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIRRAGEN® Advanced Wound Matrix |
| Version Model Number | MWM-0202 |
| Company DUNS | 080578874 |
| Company Name | ETS WOUND CARE LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B477MWM0202EA0 [Primary] |
| HIBCC | B477MWM0202SB1 [Package] Contains: B477MWM0202EA0 Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161067
FDA Product Code
| FRO | Dressing, Wound, Drug |
| QSZ | Absorbable Synthetic Wound Dressing |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
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Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2020-02-14 |
On-Brand Devices [MIRRAGEN® Advanced Wound Matrix]
| 00812005030117 | Resorbable Borate Glass Wound Management Device |
| 00812005030056 | Resorbable Borate Glass Wound Management Device |
| B477MWM0404SB1 | Resorbable Borate Glass Wound Management Device |
| B477MWM0202SB1 | Resorbable Borate Glass Wound Management Device |
| B477MWM0106SB1 | Resorbable Borate Glass Wound Management Device |
| 00812005030292 | Resorbable Borate Glass Wound Management Device |
| 00812005030230 | Resorbable Borate Glass Wound Management Device |
| 00812005030377 | Resorbable Borate Glass Wound Management Device |
| 00812005030254 | Resorbable Borate Glass Wound Management Device |
| 00812005030407 | "Resorbable Borate Glass Wound Management Device" |
| 00812005030438 | Resorbable Borate Glass Wound Management Device |
Trademark Results [MIRRAGEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIRRAGEN 87360517 5382356 Live/Registered |
ETS TECHNOLOGY HOLDINGS LLC 2017-03-06 |
 MIRRAGEN 86947403 not registered Dead/Abandoned |
Engineered Tissue Solutions, LLC 2016-03-21 |
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