Surgical Depth Gauge, Single-Use
A sterile surgical instrument designed to accurately determine the depth of a recess (usually a drilled hole). It typically consists of a moveable (sliding) centerpiece (a prong), the tip…
A sterile surgical instrument designed to accurately determine the depth of a recess (usually a drilled hole). It typically consists of a moveable (sliding) centerpiece (a prong), the tip of which is inserted into the recess; when the tip makes contact with the bottom a reading is visually taken from a scale marked on the side of the device. It is often used to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It is made of corrosive resistant materials [e.g., stainless steel, titanium (Ti), plastics]. This is a single-use device.
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
Record
| Listed by | FCI S A S FCI 20 22 |
|---|---|
| FDA product code | HNL |
| Device type | Probe, Lachrymal |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2020-03-06 |
| Record revised | 2021-11-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Length 80 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SIZER FOR SELF-RETAINING BICANALICULUS INTUBATION | Length 80 mm | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Probe | KLS-Martin L.P. | 56 |
| Ambler Surgical | Ambler Surgical, LLC | 36 |
| Millennium | Avalign Technologies, Inc. | 35 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 33 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 32 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 24 |
| Walcott Rx Products | Walcott Rx Product Inc | 24 |
| BR Surgical, LLC | BR Surgical LLC | 22 |
| Probe, Lachrymal | Geuder Aktiengesellschaft | 21 |
| Boss Instruments | Boss Instruments, Ltd. | 21 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 21 |
| Bowman Lacrimal Probe | Sontec Instruments, Inc. | 21 |
Showing 12 of 75. All products under Probe, Lachrymal
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.