MIRRASURG™
GUDID 00812005030346
Resorbable Borate Glass Wound Management Device
ETS WOUND CARE LLC
Cavity-wound management dressing, non-antimicrobial| Primary Device ID | 00812005030346 |
| NIH Device Record Key | ac3a8a2f-182f-497d-8606-3c16788f867d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIRRASURG™ |
| Version Model Number | MSG-0404 |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812005030315 [Primary] |
| GS1 | 00812005030346 [Package] Contains: 00812005030315 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 | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-09 |
| Device Publish Date | 2023-02-01 |
On-Brand Devices [MIRRASURG™]
| 00812005030339 | Resorbable Borate Glass Wound Management Device |
| 00812005030346 | Resorbable Borate Glass Wound Management Device |
| 00812005030421 | Resorbable Borate Glass Wound Management Device |
Trademark Results [MIRRASURG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIRRASURG 98079148 not registered Live/Pending |
ARGOR-HERAEUS SA 2023-07-11 |
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