Integra®
Integra® Laryngeal Mirror, Stationary Octagonal Handle, Size 000, Diameter 8 mm
4manufacturers in China registered for this device type
13catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | KAI |
| Device type | Mirror, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-24 |
| Record revised | 2023-04-17 (version 4) |
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, manufacturing date |
| Sizes | Outer diameter 8 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3734054 | Outer Diameter 22 mm | In distribution |
| 3734055 | Outer Diameter 24 mm | In distribution |
| 3734048 | 6-3/4″ | In distribution |
| 3734050 | 6-3/4″ | In distribution |
| 3734147 | 6-3/4″ | In distribution |
| 3734056 | Outer Diameter 26 mm | In distribution |
| 3734052 | Outer Diameter 16 mm | In distribution |
| 3734053 | Outer Diameter 18 mm | In distribution |
| 3734049 | 6-3/4″ | In distribution |
| 3734057 | 6-3/4″ | In distribution |
| 3734058 | Outer Diameter 30 mm | In distribution |
| 3734051 | 6-3/4″ | In distribution |
| 3722076 | 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.