Conmed
Laparoscopic Electrode with a 3/32 In. pin connector, STRAIGHT BLADE, 5 mm x 27 cm
1manufacturer
12catalogue numbers in this listing
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 | 2024-08-02 (version 9) |
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 | Storage environment temperature 50 to 90 °F; Storage environment temperature 10 to 32 °C; Storage environment humidity 10 to 90 % RH |
| Packaging | Box of 5 |
| Sizes | Length 27 to 32 cm; outer diameter 5 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 60-5159-001 | Length 32 cm | 5 | In distribution |
| 60-5163-004 | Outer Diameter 5 mm | 5 | In distribution |
| 60-5163-002 | Length 27 cm | 5 | In distribution |
| 60-5163-001 | Length 32 cm | 5 | In distribution |
| 60-5164-001 | Outer Diameter 5 mm | 5 | In distribution |
| 60-5162-001 | Length 32 cm | 5 | In distribution |
| 60-5160-002 | Outer Diameter 5 mm | 5 | In distribution |
| 60-5164-002 | Length 27 cm | 5 | In distribution |
| 60-5159-002 | Length 27 cm | 5 | In distribution |
| 60-5160-001 | Outer Diameter 5 mm | 5 | In distribution |
| 60-5164-004 | Outer Diameter 5 mm | 5 | In distribution |
| 60-5159-004 | Length 32 cm | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Handpiece | 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.