ONE
8 catalogue numbers from ROP KIT XS SPECULUM/2IN1 DEPRESSOR, listed by Moria, Inc., France, under Depressor, Orbital. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
8catalogue 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 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Moria, Inc., France |
|---|---|
| FDA product code | HNX |
| Device type | Depressor, Orbital |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2023-12-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ROP KIT XS SPECULUM/2IN1 DEPRESSOR | In distribution | |
| ONE – ROP EXAM. KIT – L | In distribution | |
| ROP KIT XS SPECULUM/2IN1 DEPRESSOR | In distribution | |
| ROP KIT XS SPECULUM/LOOP DEPRESSOR | In distribution | |
| ROP exam kit W/WS -L x10 | In distribution | |
| XS PEDIATRIC WIRE SPECULUM | In distribution | |
| ROP KIT S SPECULUM/LOOP DEPRESSOR | In distribution | |
| ONE-SCLERAL DEPRESSOR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Scleral Depressors | Aurora Surgical, LLC | 13 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 10 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 8 |
| Depressor, Orbital | DePuy Mitek, Inc. | 8 |
| Ambler Surgical | Ambler Surgical, LLC | 7 |
| Stephens Instruments | Krishna Imports Inc | 6 |
| Millennium | Avalign Technologies, Inc. | 6 |
| Duckworth & Kent | Duckworth AND Kent Limited | 5 |
| Orbit Depressor | Katena Products, Inc. | 5 |
| HNM Medical | HNM Stainless, LLC. | 5 |
| V. Mueller | Steris Corporation | 5 |
| Depressor, Orbital | Geuder Aktiengesellschaft | 5 |
Showing 12 of 48. All products under Depressor, Orbital
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.