Aesculap
JANNETTA Fork, 30 °, angled, 7 1/2", (190 mm), 2 prongs, #13, width: 1,400 mm, non-sterile, reusable
2manufacturers in China registered for this device type
45catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), 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 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | JYL |
| Device type | Hook, Microsurgical Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-24 |
| Record revised | 2023-08-25 (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 |
| Distribution end date | 2022-01-11 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OG085R | In distribution | |
| MB044R | In distribution | |
| MF421R | In distribution | |
| MA184R | In distribution | |
| MF420R | In distribution | |
| MD142 | In distribution | |
| MA388R | In distribution | |
| MF425R | In distribution | |
| MB315R | In distribution | |
| MF419R | In distribution | |
| OG015R | In distribution | |
| MF321R | In distribution | |
| MA183R | In distribution | |
| MA405R | In distribution | |
| OF361R | In distribution | |
| OG006R | In distribution | |
| MB332R | In distribution | |
| MG732R | In distribution | |
| MA489R | In distribution | |
| MA182R | In distribution | |
| MA394R | In distribution | |
| OF360R | In distribution | |
| MB055R | In distribution | |
| MA189R | In distribution | |
| MF418R | In distribution | |
| OG086R | In distribution | |
| MF422R | In distribution | |
| OG016R | In distribution | |
| MA406R | In distribution | |
| MA401R | In distribution | |
| MA188R | In distribution | |
| MF423R | In distribution | |
| MB333R | In distribution | |
| MF412R | In distribution | |
| MA395R | In distribution | |
| OG080R | In distribution | |
| MD141 | In distribution | |
| MA180R | In distribution | |
| MF413R | In distribution | |
| MA190R | In distribution | |
| MA181R | In distribution | |
| MF322R | In distribution | |
| OG084R | In distribution | |
| MF424R | In distribution | |
| MA389R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 67 |
| Sklar | Sklar Corporation | 59 |
| MicroFrance® | Integra Microfrance SAS | 48 |
| V. Mueller | Steris Corporation | 41 |
| Ambler Surgical | Ambler Surgical, LLC | 39 |
| Hook | KLS-Martin L.P. | 35 |
| Boss Instruments | Boss Instruments, Ltd. | 27 |
| Novo Surgical | Novo Surgical, Inc. | 21 |
| Integra® | Integra LifeSciences Production Corporation | 21 |
| Pilling | Teleflex Medical LLC | 17 |
| Avalign | Avalign Technologies, Inc. | 17 |
| Bear | Bear-ENT, LLC | 17 |
Showing 12 of 53. All products under Hook, Microsurgical Ear
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.