Sklar®
Censitrac Ready Paton Keratoplasty Spatula
9manufacturers in China registered for this device type
62catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (1), Shandong (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 |
| Ophsurin Co., Ltd. | Suqian | Jiangsu | Contract manufacturer | 6 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| 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 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | HND |
| Device type | Spatula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-02-25 |
| Record revised | 2020-02-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 65-4049 | In distribution | |
| 65-4012 | In distribution | |
| 65-4050 | In distribution | |
| 97-0580 | In distribution | |
| 65-4070 | In distribution | |
| 65-4038 | In distribution | |
| 65-4054 | In distribution | |
| 66-3905 | In distribution | |
| 65-4013 | In distribution | |
| 65-4064 | In distribution | |
| 65-4019C | In distribution | |
| 65-4063 | In distribution | |
| 65-4073 | In distribution | |
| 97-0582 | In distribution | |
| 97-0581 | In distribution | |
| 65-4044 | In distribution | |
| 65-4076 | In distribution | |
| 82150 | In distribution | |
| 65-4022 | In distribution | |
| 65-4045 | In distribution | |
| 65-3902 | In distribution | |
| 65-4014 | In distribution | |
| 98-797 | In distribution | |
| 65-4004 | In distribution | |
| 65-4019 | In distribution | |
| 65-4041 | In distribution | |
| 95-797 | In distribution | |
| 65-4035 | In distribution | |
| 65-3910 | In distribution | |
| 65-4047 | In distribution | |
| 65-4046 | In distribution | |
| 82145 | In distribution | |
| 65-4074 | In distribution | |
| 65-4003 | In distribution | |
| 65-4062 | In distribution | |
| 65-4052 | In distribution | |
| 66-8517 | In distribution | |
| 65-4075 | In distribution | |
| 66-3907 | In distribution | |
| 65-4010 | In distribution | |
| 65-4015 | In distribution | |
| 65-4017 | In distribution | |
| 65-4002 | In distribution | |
| 65-4078 | In distribution | |
| 65-4011 | In distribution | |
| 65-4020 | In distribution | |
| 65-3903 | In distribution | |
| 65-4072 | In distribution | |
| 65-4040 | In distribution | |
| 65-4066 | In distribution | |
| 65-4053 | In distribution | |
| 65-4051 | In distribution | |
| 65-4048 | In distribution | |
| 65-3911 | In distribution | |
| 97-0583 | In distribution | |
| 65-4042 | In distribution | |
| 65-4039 | In distribution | |
| 65-4001 | In distribution | |
| 65-4005 | In distribution | |
| 65-4068 | In distribution | |
| 65-4043 | In distribution | |
| 66-8515 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epsilon USA | Epsilon EYE Care PVT., Ltd. | 209 |
| Surgical Direct | Surgical Direct, Inc. | 201 |
| Ambler Surgical | Ambler Surgical, LLC | 164 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 155 |
| Oph.Spatula | Katena Products, Inc. | 132 |
| Ophthalmic Spatula | Katena Products, Inc. | 128 |
| Millennium | Avalign Technologies, Inc. | 103 |
| MR Phaco | Crestpoint Management Ltd. | 85 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 83 |
| Stephens Instruments | Krishna Imports Inc | 60 |
| Rumex | Rumex International Co. | 54 |
| Opthalmic Spatula | Ovation International | 50 |
Showing 12 of 401. All products under Spatula, 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.