Core Dynamics
10/12mm Fascia Anchor Adapter for Entree® Plus and Entree® II Cannula, Reusable
2manufacturers in China registered for this device type
44catalogue 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 | ConMed Corporation, United States |
|---|---|
| FDA product code | FBM |
| Device type | Cannula And Trocar, Suprapubic, Non-Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5090 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K911813 |
| Record published | 2016-09-24 |
| Record revised | 2024-07-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, box of 5, box of 20 |
| Sizes | Length 5 to 110 mm; outer diameter 0.833 to 10 mm |
| Distribution end date | 2026-03-24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CD612 | 5/10/12 Millimeter Outer Diameter ENTREE II Valve/Reducer | 10 | In distribution |
| CD516B | 5/10/12 Millimeter Outer Diameter Flip Top Reducer | 10 | In distribution |
| CD511 | 5/10 Millimeter Outer Diameter ENTREE Plus and ENTREEII Cannula | 10 | In distribution |
| CD1609FH | Length 5 mm | In distribution | |
| CD1609 | Length 5 mm | In distribution | |
| CD203 | 5 | In distribution | |
| CD513B | 5/10/12 Millimeter Outer Diameter 3 Hole Reducer | 10 | In distribution |
| CD1607 | Outer Diameter 0.875 mm | In distribution | |
| CD516 | 5/10/12 Millimeter Outer Diameter Flip Top Reducer | 10 | In distribution |
| CD1606FH | Length 5 mm | In distribution | |
| CD155 | Sealing Cap | 10 | In distribution |
| CD511B | 5/10 Millimeter Outer Diameter ENTREE Plus and ENTREEII Cannula | 10 | In distribution |
| CD1608FH | Length 5 mm | In distribution | |
| CD1610 | Outer Diameter 10 mm | In distribution | |
| CD112 | 10 | In distribution | |
| CD111 | 10 | In distribution | |
| CD155B | ENTREE Plus Cannula | 20 | Withdrawn |
| CD1512 | 100 Millimeter ENTREE Plus Cannula | Withdrawn | |
| CD6300P | Outer Diameter 5 mm | 10 | Withdrawn |
| CD200 | 5 | Withdrawn | |
| CD1610 | Outer Diameter 10 mm | Withdrawn | |
| CD1605FH | ENTREE II Cannula | Withdrawn | |
| CD153 | 3 MILLIMETER | 10 | Withdrawn |
| CD1608 | ENTREE II Cannula | Withdrawn | |
| CD1612 | Outer Diameter.833 mm | Withdrawn | |
| CD4GKM | Gasket | 5 | Withdrawn |
| CD10RLB | 5 | Withdrawn | |
| CD1610FH | Length 110 mm | Withdrawn | |
| CD1605 | ENTREE II Cannula | Withdrawn | |
| CD112B | 20 | Withdrawn | |
| CD1607 | Outer Diameter.875 mm | Withdrawn | |
| CD412 | 10/12 Millimeter Fascia Anchor Adaptor for ENTREE Plus and ENTREE II Cannula | Withdrawn | |
| CD1607FH | Outer Diameter.875 mm | Withdrawn | |
| CD188 | Sealing Cap | 10 | Withdrawn |
| CD405 | 5/5.5 Millimeter Fascia Anchor Adaptor for ENTREE Plus and ENTREE II Cannula | Withdrawn | |
| CD1608FH | ENTREE II Cannula | Withdrawn | |
| CD1609FH | ENTREE II Cannula | Withdrawn | |
| CD411 | Withdrawn | ||
| CD1606 | ENTREE II Cannula | Withdrawn | |
| CD720 | 5-12 Millimeter CORE Seal II | 10 | Withdrawn |
| CD1612FH | Outer Diameter.833 mm | Withdrawn | |
| CD111B | 20 | Withdrawn | |
| CD1606FH | ENTREE II Cannula | Withdrawn | |
| CD1609 | ENTREE II Cannula | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Carefusion 2200, Inc. | 51 |
| Ambler Surgical | Ambler Surgical, LLC | 19 |
| 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.