MIROMESH®
GUDID 00857072005019
Biologic Matrix
Miromatrix Medical Inc.
Multi-purpose surgical mesh, collagen, bioabsorbable| Primary Device ID | 00857072005019 |
| NIH Device Record Key | 42939315-019d-46f4-9075-a7377f81cd13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIROMESH® |
| Version Model Number | BLM-100-01-0808 |
| Company DUNS | 965529436 |
| Company Name | Miromatrix Medical Inc. |
| 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 Dimensions
| Height | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
| Width | 8 Centimeter |
| Height | 8 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857072005019 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K134033
FDA Product Code
| FTM | Mesh, Surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-09 |
On-Brand Devices [MIROMESH®]
| 00857072005057 | Biologic Matrix |
| 00857072005040 | Biologic Matrix |
| 00857072005033 | Biologic Matrix |
| 00857072005026 | Biologic Matrix |
| 00857072005019 | Biologic Matrix |
| 00857072005002 | Biologic Matrix |
Trademark Results [MIROMESH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIROMESH 87604939 not registered Live/Pending |
Miromatrix Medical Inc. 2017-09-12 |
 MIROMESH 86024385 4786408 Live/Registered |
Miromatrix Medical Inc. 2013-07-31 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.