MiroDry™
GUDID 00857072005521
Wound Matrix
REPRISE BIOMEDICAL, INC.
Collagen wound matrix dressing| Primary Device ID | 00857072005521 |
| NIH Device Record Key | 98074201-51a2-43df-86e8-3071fc04c7ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MiroDry™ |
| Version Model Number | 6015 |
| 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 |
Device Dimensions
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857072005521 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K240277
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 | 2024-04-05 |
| Device Publish Date | 2024-03-28 |
On-Brand Devices [MiroDry™ ]
| 00857072005545 | Wound Matrix |
| 00857072005538 | Wound Matrix |
| 00857072005521 | Wound Matrix |
| 00857072005514 | Wound Matrix |
| 00857072005507 | Wound Matrix |
| 00857072005491 | Wound Matrix |
Trademark Results [MiroDry]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIRODRY 98323666 not registered Live/Pending |
Reprise Biomedical, Inc. 2023-12-20 |
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