Unimicro
2 catalogue numbers from MND11200, listed by Unimicro Medical Systems (Shenzhen) Co., Ltd., China, under Pneumoperitoneum Needle. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
2catalogue 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 | Unimicro Medical Systems (Shenzhen) Co., Ltd., China |
|---|---|
| FDA product code | FHO |
| Device type | Pneumoperitoneum Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-12-22 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MND11200 | In distribution | |
| MND11500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 4 |
| 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 |
| 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.