Ambler Surgical
Walter foreign body spud, 4 3/4'', straight shaft with gently curved 2.0mm lance-shaped tip, flat handle
4manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| 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 |
Record
| Listed by | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | HNA |
| Device type | Spud, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Dix foreign body spud | In distribution | |
| Dix foreign body spud replacement 3 x 5.0mm needle tip | In distribution | |
| Dix foreign body spud | In distribution | |
| Francis foreign body spud | In distribution | |
| Walter foreign body spud | In distribution | |
| Golf club foreign body spud | In distribution | |
| Ellis foreign body spud | In distribution | |
| Davis foreign body spud | In distribution | |
| Dix foreign body spud | In distribution | |
| Dix foreign body spud replacement handle | In distribution | |
| Dix foreign body spud replacement flat gouge tip | In distribution | |
| Golf club foreign body spud | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Jarit® | Integra LifeSciences Production Corporation | 14 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 13 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 12 |
| Stephens Instruments | Krishna Imports Inc | 7 |
| Spud, Ophthalmic | Geuder Aktiengesellschaft | 5 |
| Spud | Katena Products, Inc. | 5 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 3 |
| Phaco Chopper | Sontec Instruments, Inc. | 3 |
| Pilling | Teleflex Medical LLC | 3 |
| Nagahara Chopper | Sontec Instruments, Inc. | 3 |
| Intracapular Manipulating Wand | Sontec Instruments, Inc. | 3 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 3 |
Showing 12 of 59. All products under Spud, 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.