Novo Surgical
mendez degree gauge, i.d. 12.0 mm
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Shanghai Lucidarx Optical LLC | Shanghai | Shanghai | Contract manufacturer | 9 |
| Danyang Guanheng Optical, Inc | Dan Yang | Jiangsu | Manufacturer | 7 |
| Danyang Shiquan Optical Co., Ltd. | Dan Yang | Jiangsu | Manufacturer | 7 |
| Jiangsu Taojing Co., Ltd. | Zhenjiang | Jiangsu | Manufacturer | 7 |
| Shenzhen Xinrun Optical Company Limited | Shenzhen | Guangdong | Manufacturer | 7 |
| Wenzhou Baibo Eyeglasses Co., Ltd. | Wenzhou | Zhejiang | Manufacturer | 5 |
Record
| Listed by | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | HLN |
| Device type | Gauge, Lens, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-12-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OP7181-97 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rumex | Rumex International Co. | 12 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 2 |
| Stephens Instruments | Krishna Imports Inc | 1 |
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.