Integra® Miltex®
Integra® Miltex® Laryngeal Mirror with Threaded Stem 4-3/4" , Size No. 00: 12mm Diameter
4manufacturers in China registered for this device type
20catalogue 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 | 2018-08-16 |
| Record revised | 2023-04-28 (version 5) |
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 |
|---|---|---|
| 23-32-0 | In distribution | |
| 23-18-7 | In distribution | |
| 23-30-00 | In distribution | |
| 23-46-7 | In distribution | |
| 23-12-4 | In distribution | |
| 23-36-2 | In distribution | |
| 23-8-2 | In distribution | |
| 23-34-1 | In distribution | |
| 23-16-6 | In distribution | |
| 23-14-5 | In distribution | |
| 23-1-000 | In distribution | |
| 23-2-00 | In distribution | |
| 23-10-3 | In distribution | |
| 23-29-000 | In distribution | |
| 23-4-0 | In distribution | |
| 23-42-5 | In distribution | |
| 23-44-6 | In distribution | |
| 23-40-4 | In distribution | |
| 23-6-1 | In distribution | |
| 23-38-3 | 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 |
| Ambler Surgical | Ambler Surgical, LLC | 20 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 19 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 15 |
| Marina Medical | Marina Medical Instruments, 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.