Ambler Value Line
Cottle septum elevator, 8 1/2'', double-ended, graduated shaft, 4.0mm x 4.0mm round end, 3.0mm wide spatula blade, flat handle
3manufacturers in China registered for this device type
5catalogue 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 Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | KAD |
| Device type | Elevator, Ent |
| 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 |
|---|---|---|
| Freer septum elevator | In distribution | |
| Cottle septum elevator | In distribution | |
| Cottle septum elevator | In distribution | |
| Pennington septum elevator | In distribution | |
| McKenty periosteal elevator | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 105 |
| MicroFrance® | Integra Microfrance SAS | 75 |
| Boss Instruments | Boss Instruments, Ltd. | 66 |
| V. Mueller | Steris Corporation | 60 |
| Novo Surgical | Novo Surgical, Inc. | 54 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 49 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 49 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 45 |
| Millennium | Avalign Technologies, Inc. | 43 |
| Pilling | Teleflex Medical LLC | 43 |
| Avalign | Avalign Technologies, Inc. | 41 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 35 |
Showing 12 of 111. All products under Elevator, 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.