Millennium
Rumel Tourniquet, flex-neck, curved,
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | EYR |
| Device type | Tourniquet, Gastro-Urology |
| Device class | Class 1 |
| Regulation | 21 CFR 878.5900 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9-65605001 | In distribution | |
| 12-678004 | In distribution | |
| 10-305498 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 8 |
| Avalign | Avalign Technologies, Inc. | 5 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 4 |
| Pilling | Teleflex Medical LLC | 4 |
| Symmetry Rumel | Aspen Surgical Products, Inc. | 2 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.