Pass OCT
Catalogue number A17110030, listed by Medicrea International, France, under Gauge, Depth. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
1catalogue number
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 | Medicrea International, France |
|---|---|
| FDA product code | HTJ |
| Device type | Gauge, Depth |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4300 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-02-01 |
| Record revised | 2022-12-01 (version 7) |
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 |
| Distribution end date | 2021-10-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A17110030 | Withdrawn |
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.