Oph.Spatula
Seibel Chopper, Angled, RH Dominant, Titanium
9manufacturers in China registered for this device type
132catalogue 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 | Katena Products, Inc., United States |
|---|---|
| FDA product code | HND |
| Device type | Spatula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-16 |
| Record revised | 2023-10-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Sizes | Width 0.25 to 2 mm; length 0.5 to 30 mm; outer diameter 0.5 mm; angle 45 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08-14529 | In distribution | |
| 08-14565R | In distribution | |
| 08-14517 | In distribution | |
| 08-14502L | In distribution | |
| 08-10144 | Length 0.7 mm | In distribution |
| 05-4067 | In distribution | |
| 08-07160 | In distribution | |
| 08-14505 | In distribution | |
| 08-16172L | In distribution | |
| 08-14564R | In distribution | |
| 05-4060 | In distribution | |
| 05-4046 | In distribution | |
| 08-14511 | In distribution | |
| 05-4043 | In distribution | |
| 05-4041 | In distribution | |
| 08-07125 | Width 1 mm | In distribution |
| 08-14562L | In distribution | |
| 08-07129 | Outer Diameter 0.5 mm | In distribution |
| 05-7007 | In distribution | |
| 05-4059 | In distribution | |
| 05-4045 | In distribution | |
| 08-14564L | In distribution | |
| 08-07115 | Length 30 mm | In distribution |
| 08-14506 | In distribution | |
| 08-07117 | In distribution | |
| 05-4064R | In distribution | |
| 08-07124 | Width 0.5 mm | In distribution |
| 08-07123 | Width 0.75 mm | In distribution |
| 08-07162 | In distribution | |
| 05-4040S | In distribution | |
| 05-4034R | In distribution | |
| 08-14503L | In distribution | |
| 08-14562R | In distribution | |
| 08-07111 | In distribution | |
| 08-14507 | In distribution | |
| 08-14528R | In distribution | |
| 05-4061 | In distribution | |
| 05-4043L | In distribution | |
| 08-10143 | In distribution | |
| 08-14535R | In distribution | |
| 08-16159 | In distribution | |
| 08-16142 | In distribution | |
| 08-14537R | In distribution | |
| 08-14561 | In distribution | |
| 08-07110 | Length 10 mm | In distribution |
| 08-14536R | In distribution | |
| 05-4062 | In distribution | |
| 05-4038 | In distribution | |
| 08-16176 | Angle 45 ° | In distribution |
| 08-07105 | Width 1 mm | In distribution |
| 05-7003 | In distribution | |
| 08-07161 | In distribution | |
| 08-07114C | In distribution | |
| 05-4036 | In distribution | |
| 08-14531L | In distribution | |
| 08-14535L | In distribution | |
| 08-14528 | In distribution | |
| 08-07130 | Width 0.5 mm | In distribution |
| 08-14516SL | In distribution | |
| 08-14536L | In distribution | |
| 08-14524 | In distribution | |
| 08-07107 | Width 0.5 mm | In distribution |
| 08-14530L | In distribution | |
| 08-14503R | In distribution | |
| 08-04414 | In distribution | |
| 08-14531 | In distribution | |
| 08-14539 | In distribution | |
| 08-14512 | In distribution | |
| 05-7007L | In distribution | |
| 05-4064L | In distribution | |
| 08-14533L | In distribution | |
| 08-14559 | In distribution | |
| 05-4042 | In distribution | |
| 08-14533R | In distribution | |
| 05-4066L | In distribution | |
| 08-04311 | In distribution | |
| 08-07113 | In distribution | |
| 08-07127 | Width 0.25 mm | In distribution |
| 08-07154 | In distribution | |
| 05-4055C | In distribution | |
| 05-4040SL | In distribution | |
| 08-04409 | In distribution | |
| 08-04310 | In distribution | |
| 08-14508 | In distribution | |
| 08-14566R | In distribution | |
| 05-4039 | In distribution | |
| 08-14509 | Length 0.5 mm | In distribution |
| 08-14568 | In distribution | |
| 05-4058 | In distribution | |
| 08-14516S | In distribution | |
| 05-4057L | In distribution | |
| 05-4032 | In distribution | |
| 05-4057 | In distribution | |
| 08-17018 | In distribution | |
| 05-4016 | In distribution | |
| 08-14530 | In distribution | |
| 08-07108 | In distribution | |
| 08-16172 | In distribution | |
| 05-4035L | In distribution | |
| 05-4065L | In distribution | |
| 08-07121 | Width 2 mm | In distribution |
| 08-07152 | In distribution | |
| 08-14516 | In distribution | |
| 08-14527L | In distribution | |
| 08-07101 | In distribution | |
| 05-4066R | In distribution | |
| 08-14504 | In distribution | |
| 08-14516L | In distribution | |
| 05-4040 | In distribution | |
| 08-14565L | In distribution | |
| 08-14502 | In distribution | |
| 08-14558 | In distribution | |
| 08-14527 | In distribution | |
| 08-07114 | In distribution | |
| 08-14508L | In distribution | |
| 05-4040L | In distribution | |
| 08-16165 | In distribution | |
| 08-14521 | In distribution | |
| 05-4050 | In distribution | |
| 05-4035 | In distribution | |
| 08-07114A | In distribution | |
| 08-14566L | In distribution | |
| 05-4055A | In distribution | |
| 05-4065R | In distribution | |
| 08-14532 | In distribution | |
| 08-14532L | In distribution | |
| 08-07112 | In distribution | |
| 05-4030 | In distribution | |
| 08-07156 | In distribution | |
| 05-4055 | In distribution | |
| 05-4052 | In distribution | |
| 08-17100 | 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 |
| Ophthalmic Spatula | Katena Products, Inc. | 128 |
| Millennium | Avalign Technologies, Inc. | 103 |
| MR Phaco | Crestpoint Management Ltd. | 85 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 83 |
| Sklar® | Sklar Corporation | 62 |
| 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.