Pilling
Lumen Finder 14 French
3manufacturers in China registered for this device type
20catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Zhejiang (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 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | KAK |
| Device type | Probe, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2026-07-07 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Length 260 to 330 mm; length 10 to 30.75 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN007921 | Length 271 mm | In distribution |
| IPN008054 | Length 30.75 in | In distribution |
| IPN007890 | Length 265 mm | In distribution |
| IPN008144 | Length 330 mm | In distribution |
| IPN008056 | Length 26.5 in | In distribution |
| IPN007920 | Length 273 mm | In distribution |
| IPN021760 | In distribution | |
| IPN924191 | Length 30.75 in | In distribution |
| IPN927643 | In distribution | |
| IPN008055 | Length 26.5 in | In distribution |
| IPN927646 | In distribution | |
| IPN927644 | In distribution | |
| IPN007923 | Length 271 mm | In distribution |
| IPN927647 | In distribution | |
| IPN021759 | In distribution | |
| IPN924193 | Length 26.5 in | In distribution |
| IPN007888 | Length 260 mm | In distribution |
| IPN007922 | Length 272 mm | In distribution |
| IPN924192 | Length 26.5 in | In distribution |
| IPN007889 | Length 10 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fentex | Fentex medical GmbH | 52 |
| MicroFrance® | Integra Microfrance SAS | 34 |
| HNM Medical | HNM Stainless, LLC. | 19 |
| Ambler Surgical | Ambler Surgical, LLC | 18 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 17 |
| mytaMed | Mytamed, Inc. | 16 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 15 |
| V. Mueller | Steris Corporation | 12 |
| Bowman salivary duct probe | Spiggle & Theis Medizintechnik Gmbh | 11 |
| Millennium | Avalign Technologies, Inc. | 10 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 10 |
| Avalign | Avalign Technologies, Inc. | 9 |
Showing 12 of 52. All products under Probe, Ent
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.