Kmedic
2 catalogue numbers from IPN014057, listed by Teleflex Medical LLC, United States, under Passer. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Qingdao Zhixing Medical Instrument Co., Ltd. | Qingdao | Shandong | Manufacturer | 6 |
| Dongguan Senmed Medical Instrument Co., Ltd. | Dongguar | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | HWQ |
| Device type | Passer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2026-02-05 (version 5) |
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, manufacturing date |
| Sizes | Length 23.5 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN014057 | Length 23.5 cm | In distribution |
| IPN014056 | Length 23.5 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex | Provision | 76 |
| Medline | Medline Industries, Inc. | 32 |
| Conmed/Linvatec | Provision | 24 |
| Stryker | Provision | 22 |
| Cylox ST | Signus Medizintechnik Gmbh | 16 |
| Apex | Stryker GmbH | 16 |
| EZ Pass | Biomet Orthopedics | 14 |
| Passer | Smith & Nephew, Inc. | 13 |
| gSource | Gsource, LLC. | 12 |
| Millennium | Avalign Technologies, Inc. | 11 |
| Medline Renewal | Medline Industries, Inc. | 9 |
| EZPass™ | Biomet Orthopedics | 7 |
Showing 12 of 130. All products under Passer
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.