Centurion
Sterile #4 Laryngeal Mirror (L500034)
4manufacturers in China registered for this device type
9catalogue 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 | Centurion Medical Products Corporation, United States |
|---|---|
| FDA product code | KAI |
| Device type | Mirror, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Premarket notification | Exempt |
| Record published | 2022-01-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 67820 | In distribution | |
| 67830 | In distribution | |
| NSBLYM5 | In distribution | |
| 67825 | In distribution | |
| 67820 | In distribution | |
| 67830 | In distribution | |
| 67825 | In distribution | |
| 67815 | In distribution | |
| I67835 | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2024-02-23 | Class II | Process control | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. | 100 units |
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.