miniRUMEL™ DEVICE 080995
GUDID 10850200006985
miniRUMEL™ DEVICE, 25cm
LSI Solutions, Inc.
Ligature loop tightener, single-use| Primary Device ID | 10850200006985 |
| NIH Device Record Key | 1b776ce5-c108-4ccc-b6ab-4ee82861e6df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | miniRUMEL™ DEVICE |
| Version Model Number | 080995 |
| Catalog Number | 080995 |
| Company DUNS | 603420183 |
| Company Name | LSI Solutions, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850200006582 [Previous] |
| GS1 | 00850200006988 [Primary] |
| GS1 | 10850200006985 [Package] Contains: 00850200006988 Package: Inner pack [12 Units] In Commercial Distribution |
FDA Product Code
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
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 | 2020-10-19 |
| Device Publish Date | 2020-10-09 |
On-Brand Devices [miniRUMEL™ DEVICE]
| 10850200006985 | miniRUMEL™ DEVICE, 25cm |
| 10850200006978 | miniRUMEL™ DEVICE, 15cm |
Trademark Results [miniRUMEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MINIRUMEL 97538967 not registered Live/Pending |
LSI Solutions, Inc. 2022-08-08 |
 MINIRUMEL 88361096 not registered Live/Pending |
LSI Solutions, Inc. 2019-03-28 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.