Epsilon USA
Sinskey Hook Angled (125 mm overall) Stainless Steel Fine Sinskey Hook Angled .12 mm Probe (125 mm overall) Stainless Steel Sinskey Hook Angled .18 mm Probe (125 mm overall) Stainless Steel…
Sinskey Hook Angled (125 mm overall) Stainless Steel Fine Sinskey Hook Angled.12 mm Probe (125 mm overall) Stainless Steel Sinskey Hook Angled.18 mm Probe (125 mm overall) Stainless Steel Sinskey Hook Angled.20 mm Probe (125 mm overall) Stainless Steel
9manufacturers in China registered for this device type
209catalogue 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 | Epsilon EYE Care PVT., Ltd., India |
|---|---|
| FDA product code | HND |
| Device type | Spatula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-16 |
| Record revised | 2024-05-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization, Ethylene Oxide |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EP-02SS | In distribution | |
| EP-59D | In distribution | |
| EP-44-9 | In distribution | |
| EPV-06 | In distribution | |
| EP-180 | In distribution | |
| EP-45SS | In distribution | |
| EP-110 | In distribution | |
| EP-204L | In distribution | |
| EP-154K | In distribution | |
| EP-97 | In distribution | |
| EP-112 | In distribution | |
| EP-19AR | In distribution | |
| EP-41 | In distribution | |
| EP-170 | In distribution | |
| EP-134 | In distribution | |
| EP-162 | In distribution | |
| EP-199 | In distribution | |
| EP-144 | In distribution | |
| EP-11 | In distribution | |
| EP-177 | In distribution | |
| P-1302L | In distribution | |
| EP-25C SS | In distribution | |
| EP-59 | In distribution | |
| EP-169 | In distribution | |
| EP-110SS | In distribution | |
| EP-25 | In distribution | |
| EC-34 | In distribution | |
| EP-124SS | In distribution | |
| EP-166 | In distribution | |
| EP-05SS | In distribution | |
| EP-25L SS | In distribution | |
| EP-100 | In distribution | |
| EP-197 | In distribution | |
| EP-35 | In distribution | |
| EP-06 | In distribution | |
| EP-77 | In distribution | |
| EP-201 | In distribution | |
| EP-10 | In distribution | |
| EP-96 | In distribution | |
| EP-19S SS | In distribution | |
| EP-05 | In distribution | |
| EP-93C | In distribution | |
| EP-58 | In distribution | |
| EP-223L | In distribution | |
| EP-82 5.75 | In distribution | |
| EP-03 | In distribution | |
| EP-15SS | In distribution | |
| EP-19SS | In distribution | |
| EP-75 | In distribution | |
| EP-203L | In distribution | |
| EP-34SS | In distribution | |
| EP-19S | In distribution | |
| EP-61 | In distribution | |
| EP-55LR | In distribution | |
| EP-76SS | In distribution | |
| EP-81 | In distribution | |
| EP-01FSS | In distribution | |
| EP-16 | In distribution | |
| EP-158 | In distribution | |
| EP-132 | In distribution | |
| EP-41SS | In distribution | |
| EP-45 | In distribution | |
| EP-91 | In distribution | |
| EP-98 | In distribution | |
| EP-64 | In distribution | |
| EP-133SS | In distribution | |
| EP-76 | In distribution | |
| EP-175RSS | In distribution | |
| EP-03SS | In distribution | |
| EP-142 | In distribution | |
| EP-02SSS | In distribution | |
| EP-160 | In distribution | |
| EP-175SS | In distribution | |
| EP-01C | In distribution | |
| EP-55L | In distribution | |
| EP-21SS | In distribution | |
| EP-40 | In distribution | |
| EP-186 SS | In distribution | |
| EP-67V SS | In distribution | |
| EP-08 | In distribution | |
| EP-01F | In distribution | |
| EP-81K | In distribution | |
| EP-178 | In distribution | |
| EP-19A | In distribution | |
| EP-90 | In distribution | |
| EP-148 | In distribution | |
| EP-182 | In distribution | |
| EP-32SS | In distribution | |
| EP-01B | In distribution | |
| EP-159SS | In distribution | |
| EP-135 | In distribution | |
| EP-09 | In distribution | |
| EP-75SS | In distribution | |
| EP-32 | In distribution | |
| EP-133 | In distribution | |
| EP-44-90 | In distribution | |
| EP-71 | In distribution | |
| P-1302R | In distribution | |
| EP-151 | In distribution | |
| EP-43 | In distribution | |
| EP-55S | In distribution | |
| EP-156 | In distribution | |
| EP-57 | In distribution | |
| EP-25C | In distribution | |
| EP-109 | In distribution | |
| EC-208 | In distribution | |
| EP-135SS | In distribution | |
| EP-111-2SS | In distribution | |
| EP-203R | In distribution | |
| EP-183 | In distribution | |
| EP-149 | In distribution | |
| EP-74SS | In distribution | |
| EP-204R | In distribution | |
| EP-118 | In distribution | |
| EP-42 | In distribution | |
| EP-175 | In distribution | |
| P-1607 SS | In distribution | |
| EP-174 | In distribution | |
| EP-74 | In distribution | |
| EP-161 | In distribution | |
| EP-68K | In distribution | |
| EP-186 | In distribution | |
| EP-05S SS | In distribution | |
| EP-59C | In distribution | |
| EP-38 | In distribution | |
| EP-184 | In distribution | |
| EP-15 | In distribution | |
| EP-152 | In distribution | |
| EP-117 | In distribution | |
| EP-92 | In distribution | |
| EP-15S | In distribution | |
| EP-155 | In distribution | |
| EP-68 | In distribution | |
| EP-21 | In distribution | |
| EP-113 | In distribution | |
| EP-94 | In distribution | |
| EP-141 | In distribution | |
| EP-56 SS | In distribution | |
| EP-64SS | In distribution | |
| EP-03H | In distribution | |
| EP-06SS | In distribution | |
| EP-223R | In distribution | |
| EP-196 | In distribution | |
| EP-59SS | In distribution | |
| EP-168 | In distribution | |
| EP-121 | In distribution | |
| EP-19 | In distribution | |
| EP-143-S | In distribution | |
| EP-13 | In distribution | |
| EP-36 | In distribution | |
| EP-02 | In distribution | |
| EP-124 | In distribution | |
| EP-01CSS | In distribution | |
| EP-25SS | In distribution | |
| EP-120 | In distribution | |
| EP-86 | In distribution | |
| EP-103 | In distribution | |
| EP-185 | In distribution | |
| EP-12 | In distribution | |
| EP-152S | In distribution | |
| EP-03HSS | In distribution | |
| EP-37 | In distribution | |
| EP-15S SS | In distribution | |
| EP-82 6.0 | In distribution | |
| EP-01 | In distribution | |
| EP-102 | In distribution | |
| EP-173 | In distribution | |
| EP-56 | In distribution | |
| EP-111 | In distribution | |
| EP-219SS | In distribution | |
| EP-01BSS | In distribution | |
| EP-67 | In distribution | |
| EP-23SS | In distribution | |
| EP-25L | In distribution | |
| EP-39L | In distribution | |
| EP-93 | In distribution | |
| EP-190 | In distribution | |
| EP-165 | In distribution | |
| EP-140 | In distribution | |
| EP-59C SS | In distribution | |
| EP-72 | In distribution | |
| EP-67SS | In distribution | |
| EP-123 | In distribution | |
| EP-02R | In distribution | |
| EP-67V | In distribution | |
| EP-05S | In distribution | |
| EP-73 | In distribution | |
| EP-77SS | In distribution | |
| EP-98SS | In distribution | |
| EP-34 | In distribution | |
| EP-176 | In distribution | |
| EC-222 SS | In distribution | |
| EP-04 | In distribution | |
| EP-01SS | In distribution | |
| EP-167 | In distribution | |
| EP-195 | In distribution | |
| EP-89 | In distribution | |
| EP-95SS | In distribution | |
| EP-23 | In distribution | |
| EP-95 | In distribution | |
| EP-193 | In distribution | |
| EP-02S | In distribution | |
| EP-122 | In distribution | |
| EP-143-A | In distribution | |
| EP-68C | In distribution | |
| EP-159 | In distribution | |
| EP-181 | In distribution | |
| EP-07 | In distribution | |
| EP-39R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.