ReSolve® RBC-12-038/D
GUDID 10884450683900
Merit Medical Systems, Inc.
Biliary drain| Primary Device ID | 10884450683900 |
| NIH Device Record Key | b0173a33-d3db-48e0-948f-2f272e5204d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ReSolve® |
| Version Model Number | 00884450683903 |
| Catalog Number | RBC-12-038/D |
| Company DUNS | 184763290 |
| Company Name | Merit Medical Systems, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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
| Device Size Text, specify | 0 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450683903 [Primary] |
| GS1 | 10884450683900 [Package] Contains: 00884450683903 Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141408
FDA Product Code
| FGE | Stents, drains and dilators for the biliary ducts |
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 | 2023-07-10 |
| Device Publish Date | 2023-07-01 |
On-Brand Devices [ReSolve®]
| 10884450362997 | 00884450362990 |
| 10884450362980 | 00884450362983 |
| 10884450362973 | 00884450362976 |
| 10884450362966 | 00884450362969 |
| 10884450362959 | 00884450362952 |
| 10884450361464 | 00884450361467 |
| 10884450361457 | 00884450361450 |
| 10884450361440 | 00884450361443 |
| 10884450313302 | 00884450313305 |
| 10884450313296 | 00884450313299 |
| 10884450313289 | 00884450313282 |
| 10884450313272 | 00884450313275 |
| 10884450313265 | 00884450313268 |
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| 10884450313241 | 00884450313244 |
| 10884450313234 | 00884450313237 |
| 10884450231644 | 00884450231647 |
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| 10884450009489 | 00884450009482 |
Trademark Results [ReSolve]
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