Integra®
Integra® Castroviejo Caliper, 0-20 mm Scale, Straight
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| 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 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | HOE |
| Device type | Caliper, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-26 |
| Record revised | 2023-04-17 (version 3) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3740009 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MR Phaco | Crestpoint Management Ltd. | 55 |
| Ambler Surgical | Ambler Surgical, LLC | 20 |
| Millennium | Avalign Technologies, Inc. | 17 |
| Duckworth & Kent | Duckworth AND Kent Limited | 15 |
| Castroviejo Caliper | Sontec Instruments, Inc. | 11 |
| gSource | Gsource, LLC. | 10 |
| Ophthalmic Caliper | Katena Products, Inc. | 10 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 9 |
| Walcott Rx Products | Walcott Rx Product Inc | 8 |
| Caliper, Ophthalmic | Black & Black Surgical, Inc. | 8 |
| Boss Instruments | Boss Instruments, Ltd. | 8 |
| V. Mueller | Steris Corporation | 7 |
Showing 12 of 108. All products under Caliper, Ophthalmic
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.