LHB Industries
Male External Catheter, Medium 29 mm, Non Latex w/ skin Wipe
5manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Xiamen HOY Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | The Lighthouse For the Blind, Inc., United States |
|---|---|
| FDA product code | KOA |
| Device type | Surgical Instruments, G-U, Manual (And Accessories) |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Premarket notification | Exempt |
| Record published | 2021-10-01 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Wide Band Intermed | In distribution | |
| Ultra Flex Medium w/ wipes | In distribution | |
| Ultra Flex XL | In distribution | |
| Ultra Flex Large | In distribution | |
| Ultra Flex Small | In distribution | |
| UltraFlex Small w/ wipe | In distribution | |
| Wide Band Large | In distribution | |
| Wide Band Medium | In distribution | |
| Ultra Flex Medium | In distribution | |
| Wide Band Small | In distribution | |
| Ultra Flex XL w/wipe | In distribution | |
| Ultra Flex Large w/wipe | In distribution | |
| Ultra Flex Intermed w/ wipe | In distribution | |
| Ultra Flex Intermed | In distribution | |
| Wide Band Large w/ wipe | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed | Elmed, Inc. | 233 |
| Millennium | Avalign Technologies, Inc. | 64 |
| Elmed Incorporated | Elmed, Inc. | 58 |
| Ambler Surgical | Ambler Surgical, LLC | 35 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 33 |
| Cardinal Health | Cardinal Health 200, LLC | 30 |
| Novo Surgical | Novo Surgical, Inc. | 29 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 23 |
| Zoll-Dental | Zoll-Dental | 13 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 13 |
| Cook | Cook Incorporated | 8 |
| Quinelato | Schobell Industrial Ltda | 7 |
Showing 12 of 74. All products under Surgical Instruments, G-U, Manual (And Accessories)
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.