Ambler Surgical
Outer sheath with luer lock, insulated, 10.0mm diameter, 210.0mm working length
2manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
All of them in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
Record
| Listed by | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | FBM |
| Device type | Cannula And Trocar, Suprapubic, Non-Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5090 |
| 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 |
|---|---|---|
| ArthFlow® obturator | In distribution | |
| Outer sheath with luer lock | In distribution | |
| ArthFlow® obturator | In distribution | |
| Replacement sheath for Storz-style kleppinger | In distribution | |
| Outer sheath | In distribution | |
| Outer sheath with luer lock | In distribution | |
| Outer sheath | In distribution | |
| Outer sheath with luer lock | In distribution | |
| Outer sheath | In distribution | |
| Outer sheath | In distribution | |
| ArthFlow® operating sheath | In distribution | |
| Outer sheath with luer lock | In distribution | |
| Outer sheath with luer lock | In distribution | |
| Outer sheath | In distribution | |
| Outer sheath with luer lock | In distribution | |
| Outer sheath | In distribution | |
| ArthFlow® operating sheath | In distribution | |
| Outer sheath | In distribution | |
| Outer sheath | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Carefusion 2200, Inc. | 51 |
| Core Dynamics | ConMed Corporation | 44 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 19 |
| HNM Medical | HNM Stainless, LLC. | 15 |
| V. Mueller | Steris Corporation | 7 |
| Anmuth Medical International | Anmuth Medical International LLC | 7 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 5 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 3 |
| Snowden-Pencer | Carefusion 2200, Inc. | 2 |
| Visualase | Medtronic Navigation, Inc. | 2 |
| 3.5 mm Reusable Trocars-Cannulae | Flexbar Machine Corp. | 2 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 2 |
Showing 12 of 13. All products under Cannula And Trocar, Suprapubic, Non-Disposable
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.