MIRRAGEN® Advanced Wound Matrix
GUDID B477MWM0106SB1
Resorbable Borate Glass Wound Management Device
ETS WOUND CARE LLC
Cavity-wound management dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing| Primary Device ID | B477MWM0106SB1 |
| NIH Device Record Key | 4c5d8f66-72ac-4761-a526-476db137f972 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIRRAGEN® Advanced Wound Matrix |
| Version Model Number | MWM-0106 |
| 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 | B477MWM0106EA0 [Primary] |
| HIBCC | B477MWM0106SB1 [Package] Contains: B477MWM0106EA0 Package: Box [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161067
FDA Product Code
| FRO | Dressing, Wound, Drug |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
[B477MWM0106SB1]
Radiation Sterilization
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" |
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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