Core Dynamics
120mm C02 Insufflation Needle
4manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1), Tianjin (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Unimicro Medical Systems (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Tianjin Uwell Medical Device Manufacturing Co Ltd | Tianjin | Tianjin | Manufacturer | 3 |
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | FHO |
| Device type | Pneumoperitoneum Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K914426 |
| Record published | 2016-09-24 |
| Record revised | 2023-06-05 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 32 °C; Storage environment temperature 50 to 90 °F |
| Packaging | Box of 10, box of 40 |
| Sizes | Needle gauge 14 G; length 120 to 150 mm |
| Distribution end date | 2022-06-08 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CD7212 | Needle Gauge 14 G | 10 | In distribution |
| CD7212NSB | 40 | In distribution | |
| CD7215 | Length 150 mm | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 4 |
| Excel | ConMed Corporation | 2 |
| Pneumo-Matic | Coopersurgical, Inc. | 2 |
| Surgineedle | Covidien LP | 2 |
| V. Mueller | Steris Corporation | 2 |
| AccuMedx | Accumedx, LLC | 2 |
| Unimicro | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2 |
| Oneport | ConMed Corporation | 1 |
| Insufflation NEEDLE,12CM | Ranfac Corp. | 1 |
| Veress Needle | Unimax Medical Systems Inc. | 1 |
| Insufflation NEEDLE,15CM | Ranfac Corp. | 1 |
| THL | Gyrus Acmi, Inc. | 1 |
Showing 12 of 13. All products under Pneumoperitoneum Needle
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.