Cardinal Health
Testosterone Insertion Packet
5manufacturers in China registered for this device type
30catalogue 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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | KOA |
| Device type | Surgical Instruments, G-U, Manual (And Accessories) |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-08-16 |
| Record revised | 2022-06-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 15, case of 14, case of 5, case of 8, case of 10, case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SBA33VPCEA | In distribution | |
| SOT33VBCE1 | In distribution | |
| SOT54VTAUA | In distribution | |
| SBA45VPEAA | In distribution | |
| 13-0116A | In distribution | |
| 13-4392A | In distribution | |
| SOT54VTAU1 | In distribution | |
| SOT33VBCEB | In distribution | |
| SOT33VBCEC | In distribution | |
| 17B4392B | In distribution | |
| 13-0116B | In distribution | |
| 13-4392B | In distribution | |
| 17-9221A | In distribution | |
| 17B4392A | In distribution | |
| 07-9221A | In distribution | |
| 17-1861A | In distribution | |
| SBAOCVSLAE | In distribution | |
| SBA44VSVAB | In distribution | |
| 17-1076A | In distribution | |
| SMA7LVBZMA | In distribution | |
| SOTOCVPRMA | In distribution | |
| SBAOCVPRMB | In distribution | |
| SOT33VPCEA | In distribution | |
| 17B4392D | In distribution | |
| 17-4014A | In distribution | |
| SOT33VBCED | In distribution | |
| SOT33VPCEB | In distribution | |
| SOT33VBCEA | In distribution | |
| SBA33VBCEA | In distribution | |
| SBAOCVPRM1 | 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 |
| Novo Surgical | Novo Surgical, Inc. | 29 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 23 |
| LHB Industries | The Lighthouse For the Blind, Inc. | 15 |
| 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.