Premier Edge® Microsurgical Knives
Microsurgical Knife 1.5mm Thin Slit Knife, Safety Line (Single Bevel Blade)
12manufacturers in China registered for this device type
69catalogue numbers in this listing
36recalls on this code
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| 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 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
| 2nd Sight Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 1 |
| Shaanxi Xingmao Industry Co., Ltd. | Xi An | Shaanxi | Private-label distributor | 1 |
Record
| Listed by | Oasis Medical, Inc., United States |
|---|---|
| FDA product code | HNN |
| Device type | Knife, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-04-30 |
| Record revised | 2023-10-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 6, plastic bag of 50 |
| Sizes | Width 0.06 to 0.126 in; width 0.104 to 5 mm; angle 15 to 40 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PE4815-SL, B-PE4815-SL | In distribution | |
| PE3122, B-PE3122 | In distribution | |
| PE3022, B-PE3022 | Angle 22.5 ° | In distribution |
| PE3523, B-PE3523 | In distribution | |
| PE3015-5, B-PE3015-5 | Width 5 mm | In distribution |
| PE3622, B-PE3622 | In distribution | |
| PE3520A, B-PE3520A | In distribution | |
| PE3030, B-PE3030 | In distribution | |
| PE4827-TL, B-PE4827-TL | Width 0.108 in | In distribution |
| PE4824-TL, B-PE4824-TL | Width 0.094 in | In distribution |
| PE3302, B- PE3302 | In distribution | |
| PE3519, B-PE3519 | In distribution | |
| PE3720, B-PE3720 | Width 2.0 mm | In distribution |
| PE3818, B-PE3818 | In distribution | |
| PE4832-TL, B-PE4832-TL | Width 0.126 in | In distribution |
| PE3010-SL, B-PE3010-SL | In distribution | |
| PE3720A, B-PE3720A | Width 2.0 mm | In distribution |
| PE3226, B-PE3226 | In distribution | |
| PE3132, B-PE3132 | In distribution | |
| PE3010, B-PE3010 | In distribution | |
| PE3015, B-PE3015 | Angle 15 ° | In distribution |
| PE3520A-SL, B-PE3520A-SL | In distribution | |
| PE3015-SL, B-PE3015-SL | In distribution | |
| PE3014, B-PE3014 | In distribution | |
| PE3228, B-PE3228 | In distribution | |
| PE4830-TL, B-PE4830-TL | Width 0.118 in | In distribution |
| PE3525-SL, B-PE3525-SL | In distribution | |
| PE3452, B-PE3452 | In distribution | |
| PE3830, B-PE3830 | In distribution | |
| PE4820-SL, B-PE4820-SL | In distribution | |
| PE3045, B-PE3045 | In distribution | |
| PE3523A, B-PE3523A | In distribution | |
| PE4828-SL, B-PE4828-SL | In distribution | |
| PE4826-SL, B-PE4826-SL | In distribution | |
| PE4822-TL, B-PE4822-TL | Width 0.087 in | In distribution |
| PE4827-SL, B-PE4827-SL | In distribution | |
| PE3125, B-PE3125 | In distribution | |
| PE3520-SL | In distribution | |
| PE3230, B-PE3230 | In distribution | |
| PE4830-SL, B-PE4830-SL | In distribution | |
| PE3520, B-PE3520 | In distribution | |
| PE4828-TL, B-PE4828-TL | Width 0.112 in | In distribution |
| PE3128, B-PE3128 | In distribution | |
| PE3832S, B-PE3832S | Width 3.2 mm | In distribution |
| PE4822-SL, B-PE4822-SL | In distribution | |
| PE3525, B-PE3525 | In distribution | |
| PE3015-3, B-PE3015-3 | Width 3.0 mm | In distribution |
| PE3832, B-PE3832 | In distribution | |
| PE3826, B-PE3826 | In distribution | |
| PE3227, B-PE3227 | In distribution | |
| PE3127, B-PE3127 | In distribution | |
| PE3828, B-PE3828 | In distribution | |
| PE3519A, B-PE3519A | In distribution | |
| PE3440, B-PE3440 | In distribution | |
| PE3300, B- PE3300 | In distribution | |
| PE3126, B-PE3126 | In distribution | |
| PE4820-TL, B-PE4820-TL | Width 0.079 in | In distribution |
| PE4826-TL, B-PE4826-TL | Width 0.104 mm | In distribution |
| PE3827, B-PE3827 | Width 2.75 mm | In distribution |
| PE3301, B-PE3301 | In distribution | |
| PE4824-SL, B-PE4824-SL | In distribution | |
| PE3303, B-PE3303 | In distribution | |
| PE3825, B-PE3825 | In distribution | |
| PE3128-SL, B-PE3128-SL | In distribution | |
| PE3630, B- PE3630 | In distribution | |
| PE4832-SL, B-PE4832-SL | In distribution | |
| PE3012, B-PE3012 | Width 1.2 mm | In distribution |
| PE3519-SL, B-PE3519-SL | In distribution | |
| PE3824, B-PE3824 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 283 |
| Mani Ophthalmic Knife | Mani, Inc. | 234 |
| Unique Edge | Unique Technologies, Inc. | 186 |
| Sharpoint | Surgical Specialties México, S. de R.L. de C.V. | 162 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 154 |
| Mastel Precision Surgical Instruments, Inc. | Mastel Surgical Inc. | 146 |
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 115 |
| Ophthalmic Knife | Ovation International | 81 |
| Ophthalmic Knife | Katena Products, Inc. | 72 |
| Micro Feather Disposable Ophthalmic Scalpel with plastic handle | Feather Safety Razor Co., Ltd. | 63 |
| ExactEtch | Diamatrix | 63 |
| Micro Feather Ophthalmic Scalpel with aluminum handle | Feather Safety Razor Co., Ltd. | 62 |
Showing 12 of 434. All products under Knife, Ophthalmic
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-07-18 | Not classified | Device Design | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL | 28,319 individual knives (Z-0485-0516-2008) | 2009-09-25 |
| 2007-06-08 | Not classified | Device Design | This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. | 2009-09-25 | |
| 2007-06-08 | Not classified | Device Design | This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. | 2009-09-25 | |
| 2007-06-08 | Not classified | Device Design | This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. | 2009-09-25 | |
| 2007-06-08 | Not classified | Device Design | This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. | 2009-09-25 |
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.