BR Surgical, LLC
POLITZER air bag complete, w/ 4 tips & connecting nozzle
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yearstar Healthcare Technology Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 43 |
| Huizhou Kaiyi Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 3 |
Record
| Listed by | BR Surgical LLC, United States |
|---|---|
| FDA product code | KCL |
| Device type | Blower, Powder, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5220 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BR44-09000 | In distribution | |
| BR44-09122 | In distribution | |
| BR44-09101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Blower, Powder, Ent | Karl Storz GmbH & Co. KG | 16 |
| Sheehy-House Powder Insufflator | Oto Med Inc | 1 |
| Kabierske Powder Blower Cannula | Sontec Instruments, Inc. | 1 |
| Dryswab | Medical Wire & Equipment Company (Bath), Ltd. | 1 |
| Kabierske Powder Blower SET | Sontec Instruments, Inc. | 1 |
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.