Coagulator, Laparoscopic, Unipolar (And Accessories)
Laparoscopic Electrode with 4mm Pin and Disposable Cord
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | HFG |
| Device type | Coagulator, Laparoscopic, Unipolar (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4160 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K904240 |
| Record published | 2016-09-24 |
| Record revised | 2019-02-07 (version 4) |
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 |
| Storage | Handling environment temperature -20 to 140 °F; Storage environment humidity 30 to 75 % RH; Storage environment humidity 10 to 90 % RH; Handling environment temperature -29 to 60 °C; Storage environment temperature 10 to 32 °C; Handling environment humidity up to 85 % RH |
| Packaging | Box of 5 |
| Sizes | Length 32 cm; outer diameter 5 mm |
| Distribution end date | 2016-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 60-5160-004 | Length 32 cm | 5 | Withdrawn |
Same Product Code
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|---|---|---|
| Conmed | ConMed Corporation | 12 |
| Acessa ProVu System | Hologic, Inc. | 8 |
| Generator | Halt Medical, Inc. | 1 |
| Guidance controller | Halt Medical, Inc. | 1 |
| Guidance field generator | Halt Medical, Inc. | 1 |
| Acessa ProVu Dual Foot Pedal | Acessa Health, Inc. | 1 |
| Guidance handpiece | Halt Medical, Inc. | 1 |
| Handpiece cable | Halt Medical, Inc. | 1 |
| Guidance handpiece cable | Halt Medical, Inc. | 1 |
| Guidance ultrasound transducer sleeve | Halt Medical, Inc. | 1 |
| Pads | Halt Medical, Inc. | 1 |
| Pad cable | Halt Medical, Inc. | 1 |
Showing 12 of 14. All products under Coagulator, Laparoscopic, Unipolar (And Accessories)
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.