PMT® Corporation
IN-Line Tunneling Needle, Short
4manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Hotry Co., Ltd. | Beijing | Beijing | Manufacturer | 9 |
Record
| Listed by | PMT Corp., United States |
|---|---|
| FDA product code | HAO |
| Device type | Instrument, Surgical, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4535 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-28 |
| Record revised | 2024-02-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Sizes | Needle gauge 13 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2105-5 | Needle Gauge 13 G | In distribution |
| 2105-9 | In distribution | |
| 2105-6 | Needle Gauge 13 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 705 |
| Ambler Surgical | Ambler Surgical, LLC | 597 |
| V. Mueller | Steris Corporation | 577 |
| Millennium | Avalign Technologies, Inc. | 383 |
| Avalign | Avalign Technologies, Inc. | 352 |
| Novo Surgical | Novo Surgical, Inc. | 300 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 283 |
| Boss Instruments | Boss Instruments, Ltd. | 263 |
| Pilling | Teleflex Medical LLC | 156 |
| Instrument, Surgical, Non-Powered | Karl Storz GmbH & Co. KG | 130 |
| Instrument, Surgical, Non-Powered | Fehling Instruments GmbH | 126 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 109 |
Showing 12 of 249. All products under Instrument, Surgical, Non-Powered
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.