Ambler Surgical
Saunders-Paparella stapes hook, 6 1/2'', malleable, straight shaft, angled 90 degrees, #1, 0.33mm long tip, hexagonal handle
2manufacturers in China registered for this device type
39catalogue 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 | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | JYL |
| Device type | Hook, Microsurgical Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-04 |
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 |
|---|---|---|
| Schuknecht foot plate hook | In distribution | |
| Shea stapes hook | In distribution | |
| Jordan hook | In distribution | |
| Shea stapes hook | In distribution | |
| Robinson-Moon prosthesis inserter | In distribution | |
| Shea oblique hook | In distribution | |
| Lucae ear hook | In distribution | |
| Shambaugh-Derlacki hook/spud | In distribution | |
| Jordan hook | In distribution | |
| Shea fenestration hook | In distribution | |
| Shea foot plate hook | In distribution | |
| Hough-Saunders-Paparella hook | In distribution | |
| Jansen ear hook | In distribution | |
| Austin foot plate hook | In distribution | |
| House hook | In distribution | |
| Schuknecht stapes hook | In distribution | |
| Shea foot plate hook | In distribution | |
| Austin foot plate hook | In distribution | |
| Saunders-Paparella stapes hook | In distribution | |
| Allport incus hook | In distribution | |
| Day ear hook | In distribution | |
| Schuknecht foot plate hook | In distribution | |
| Day ear hook | In distribution | |
| Shambaugh micro hook | In distribution | |
| Gross ear hook and spoon | In distribution | |
| Saunders-Paparella stapes hook | In distribution | |
| Shambaugh-Derlacki hook | In distribution | |
| Jordan hook | In distribution | |
| House hook | In distribution | |
| Lucae ear hook | In distribution | |
| Schuknecht stapes hook | In distribution | |
| Jansen ear hook | In distribution | |
| Lillie ear hook | In distribution | |
| Schuknecht foot plate hook | In distribution | |
| Schuknecht foot plate hook | In distribution | |
| Lucae ear hook | In distribution | |
| Day ear hook | In distribution | |
| Saunders-Paparella stapes hook | In distribution | |
| Shea fistula hook | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 67 |
| Sklar | Sklar Corporation | 59 |
| MicroFrance® | Integra Microfrance SAS | 48 |
| Aesculap | Aesculap AG | 45 |
| V. Mueller | Steris Corporation | 41 |
| 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.