Novo Surgical
large screw depth gauge, up to 100.0 mm, 8 3/4" (22.2 cm)
14manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Jiangsu (3), Zhejiang (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Showing 12 of 14. All 14 manufacturers in China registered for Gauge, Depth
Record
| Listed by | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | HTJ |
| Device type | Gauge, Depth |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4300 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-12-18 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N8921-00 | In distribution | |
| N6862-09 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gauge, Depth | Synthes Gmbh | 119 |
| Acetabular Shell Gauge | Biomet Orthopedics | 57 |
| Arthrex® | Arthrex, Inc. | 34 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 33 |
| Gauge, Depth | AAP Implantate AG | 33 |
| Newclip Instruments | Newclip Technics SAS | 28 |
| Recap® Femoral Head Resurfacing | Biomet Orthopedics | 23 |
| Tecomet | Tecomet, Inc. | 23 |
| Apex Knee System | Omni Life Science, Inc. | 22 |
| Ring-LOC(R) Acetabular Trial | Biomet Orthopedics | 21 |
| Depth gauge | Jeil Medical Corporation | 19 |
| Dyna Locking Trochanteric Nail | CG MedTech Co., Ltd. | 19 |
Showing 12 of 614. All products under Gauge, Depth
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.