Ocular Exam Neonatal Speculum
Disposable Neonatal Speculum
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Nanhai YI XIN Plastic Tableware Manufacturing Co Ltd | Foshan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Neotech Products, LLC, United States |
|---|---|
| FDA product code | FXG |
| Device type | Specula Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-06-14 |
| Record revised | 2022-07-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10812594012515 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® | Integra LifeSciences Production Corporation | 3 |
| BR Surgical, LLC | BR Surgical LLC | 3 |
| Neotech Ocular Exam Kit | Neotech Products, LLC | 2 |
| Ambler Surgical | Ambler Surgical, LLC | 1 |
| Ocular Exam Depressor | Neotech Products, LLC | 1 |
| Ear funnel, grey, small, Ø 2,5 mm, PU = 1000 pcs. | Kirchner & Wilhelm GmbH + Co.KG | 1 |
| Ocular Exam Standard Speculum | Neotech Products, LLC | 1 |
| Realstar Surgical Instruments | Real Star Surgical Instruments | 1 |
| Ear funnel, grey, small Ø 2.5 mm, 10 x 100 pcs. in polybag | Kirchner & Wilhelm GmbH + Co.KG | 1 |
| Ear funnel, grey, large Ø 4.0 mm, 10×100 pcs. in polybag | Kirchner & Wilhelm GmbH + Co.KG | 1 |
| Ear funnel, black, large Ø 4.0 mm, in units of 100 pcs. | Kirchner & Wilhelm GmbH + Co.KG | 1 |
| Pilling | Teleflex Medical LLC | 1 |
Showing 12 of 25. All products under Specula Accessories
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.