Miro3D®
GUDID 00857072005347
Wound Matrix
REPRISE BIOMEDICAL, INC.
Collagen wound matrix dressing| Primary Device ID | 00857072005347 |
| NIH Device Record Key | 3a0e9b03-a658-4d63-9085-9eb8962b5814 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Miro3D® |
| Version Model Number | 3015 |
| Company DUNS | 043611421 |
| Company Name | REPRISE BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
| Length | 10 Centimeter |
| Width | 5 Centimeter |
| Height | 2 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857072005347 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221520
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 | 2022-11-29 |
| Device Publish Date | 2022-11-21 |
On-Brand Devices [Miro3D®]
| 00857072005347 | Wound Matrix |
| 00857072005330 | Wound Matrix |
| 00857072005323 | Wound Matrix |
| 00857072005316 | Wound Matrix |
| 00857072005569 | Wound Matrix |
| 00857072005552 | 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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