MiroFlex®
GUDID 00857072005385
Biologic Matrix
REPRISE BIOMEDICAL, INC.
Extra-gynaecological surgical mesh, collagen, bioabsorbable| Primary Device ID | 00857072005385 |
| NIH Device Record Key | 2cef6ae8-f19e-4ac2-9fd9-0ea92ef5c764 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MiroFlex® |
| Version Model Number | BLM-100-01-1016 |
| Company DUNS | 043611421 |
| Company Name | REPRISE BIOMEDICAL, 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
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 Centimeter |
| Width | 10 Centimeter |
| Height | 16 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857072005385 [Primary] |
FDA Product Code
| FTM | Mesh, Surgical |
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 | 2023-05-18 |
| Device Publish Date | 2023-05-10 |
On-Brand Devices [MiroFlex®]
| 00857072005408 | Biologic Matrix |
| 00857072005385 | Biologic Matrix |
| 00857072005361 | Biologic Matrix |
| 00857072005354 | Biologic Matrix |
| 00857072005392 | Biologic Matrix |
| 00857072005378 | Biologic Matrix |
Trademark Results [MiroFlex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIROFLEX 90075742 not registered Live/Pending |
Reprise Biomedical, Inc. 2020-07-27 |
 MIROFLEX 71590627 0560090 Dead/Expired |
UNIVERSAL PAINT & VARNISH COMPAY 1950-01-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.