DeRoyal
Pneumoperitoneum Needle
4manufacturers in China registered for this device type
4catalogue 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 | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | FHO |
| Device type | Pneumoperitoneum Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10, case of 40, case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28-0602 | In distribution | |
| 28-0612 | In distribution | |
| 28-0601 | In distribution | |
| 28-0611 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Core Dynamics | ConMed Corporation | 3 |
| 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.