Novo Surgical Inc.
zenith laryngeal mirror, octagon handle, 8" (20.3 cm), size 7, 24.0 mm
4manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (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 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Bestway Plastic And Metal Products Ltd. | Dongguan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | KAI |
| Device type | Mirror, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-11-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E8459-33 | In distribution | |
| E8459-29 | In distribution | |
| E8459-31 | In distribution | |
| E8459-39 | In distribution | |
| E8459-37 | In distribution | |
| E8459-27 | In distribution | |
| E8459-23 | In distribution | |
| E8459-35 | In distribution | |
| E8459-21 | In distribution | |
| E98459-35 | In distribution | |
| E98459-31 | In distribution | |
| E8459-25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hahnenkratt | E. Hahnenkratt Gmbh | 49 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 32 |
| Mirror | KLS-Martin L.P. | 28 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 28 |
| Aesculap | Aesculap AG | 27 |
| Laryngeal Mirror | Sontec Instruments, Inc. | 27 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 24 |
| Millennium | Avalign Technologies, Inc. | 24 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 20 |
| Ambler Surgical | Ambler Surgical, LLC | 20 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 19 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 15 |
Showing 12 of 44. All products under Mirror, Ent
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.