Miro3D® Fibers
GUDID 00857072005422
Wound matrix
REPRISE BIOMEDICAL, INC.
Collagen wound matrix dressing| Primary Device ID | 00857072005422 |
| NIH Device Record Key | 07682a25-ffc6-428e-9006-be533f3c4f93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Miro3D® Fibers |
| Version Model Number | 4005 |
| 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
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
| Weight | 250 Milligram |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857072005422 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| KGN | Wound Dressing With Animal-Derived Material(S) |
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 | 2022-12-01 |
| Device Publish Date | 2022-11-23 |
On-Brand Devices [Miro3D® Fibers]
| 00857072005446 | Wound matrix |
| 00857072005439 | Wound matrix |
| 00857072005422 | Wound matrix |
| 00857072005415 | Wound matrix |
Trademark Results [Miro3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIRO3D 90075721 not registered Live/Pending |
Reprise Biomedical, Inc. 2020-07-27 |
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