Millennium
Universal Otologic Retractor, OL 7", Scissor Handle, DE 4 Prong End, DE Pointed Serrated Elevator End
3manufacturers in China registered for this device type
47catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (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 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | KAL |
| Device type | Retractor, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-28 |
| Record revised | 2023-07-06 (version 2) |
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 |
|---|---|---|
| 2-4880 | In distribution | |
| 1-B61021 | In distribution | |
| 2-6752 | In distribution | |
| 2-4830 | In distribution | |
| 2-6760 | In distribution | |
| 9-21211 | In distribution | |
| 10-450401 | In distribution | |
| 2-1685P60L | In distribution | |
| 85-23081254 | In distribution | |
| 1-MCLT10 | In distribution | |
| 85-23067498 | In distribution | |
| 2-4287 | In distribution | |
| 10-460435 | In distribution | |
| 85-20077159 | In distribution | |
| 1-450125 | In distribution | |
| 85-20077152 | In distribution | |
| 2-4870 | In distribution | |
| 2-4288 | In distribution | |
| 2-4285 | In distribution | |
| 91-74040I | In distribution | |
| 2-4843 | In distribution | |
| 2-6200 | In distribution | |
| 1-991MC1 | In distribution | |
| 17-090090 | In distribution | |
| 85-14018280 | In distribution | |
| 0-52156 | In distribution | |
| 2-4770 | In distribution | |
| 2-4820 | In distribution | |
| 2-4844 | In distribution | |
| 85-23081250 | In distribution | |
| 1-RH4590 | In distribution | |
| 85-23081258 | In distribution | |
| 1-450128 | In distribution | |
| 1-450126 | In distribution | |
| 2-1685P60R | In distribution | |
| 0-52166 | In distribution | |
| 10-290100 | In distribution | |
| 2-6750 | In distribution | |
| 2-4842 | In distribution | |
| 2-2842 | In distribution | |
| 10-385255 | In distribution | |
| 2-4882 | In distribution | |
| 2-4870 | In distribution | |
| 85-21067443 | In distribution | |
| 17-090103 | In distribution | |
| 85-20077172 | In distribution | |
| 2-4750 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Steris Corporation | 138 |
| Ambler Surgical | Ambler Surgical, LLC | 105 |
| Pilling | Teleflex Medical LLC | 90 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 89 |
| Boss Instruments | Boss Instruments, Ltd. | 61 |
| Avalign | Avalign Technologies, Inc. | 54 |
| Fentex | Fentex medical GmbH | 54 |
| Novo Surgical | Novo Surgical, Inc. | 52 |
| Aesculap | Aesculap AG | 46 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 43 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 42 |
| HNM Medical | HNM Stainless, LLC. | 39 |
Showing 12 of 80. All products under Retractor, 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.