OWL
OWL Sterile Single USE Disposable Facet Denervation R.F. Probe/Temperature Sensor FOR 15 CM Cannula (Thermocouple)
1manufacturer
345catalogue numbers in this listing
5510(k) clearances naming this product code
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 |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Diros Technology, Inc., Canada |
|---|---|
| FDA product code | GXI |
| Device type | Probe, Radiofrequency Lesion |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4725 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K010202 |
| Record published | 2016-09-01 |
| Record revised | 2023-05-03 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 30 °C; Storage environment humidity 15 to 85 % RH; Special storage condition: Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight |
| Packaging | Box of 10, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 466-150-S | In distribution | |
| 467-022/54/5-SC | In distribution | |
| DTRH-018/200/5 | In distribution | |
| 463-003-C | In distribution | |
| 466-020/50/5 | In distribution | |
| DHC-020/50/5-SC | In distribution | |
| D466-020 | In distribution | |
| 466-020/50/10-SC | In distribution | |
| 465-001-S | In distribution | |
| DHC-018/100/10-SC | In distribution | |
| 466-016/150/10-SC | In distribution | |
| 466-004/150/10-SRC-S | In distribution | |
| DHC-020/200/20-SC | In distribution | |
| DHC-020/60/5-B | In distribution | |
| DTRH-020/200/5 | In distribution | |
| DHC-016/50/10-SC | In distribution | |
| DHC-022/50/4 | In distribution | |
| 466-020/60/10-SC | In distribution | |
| DHC-021/100/5 | In distribution | |
| DHC-018/200/10-SC | In distribution | |
| D466-005 | In distribution | |
| DXE-022/100/5 | In distribution | |
| DST-023/100 | In distribution | |
| 463-070-S | In distribution | |
| 467-022/100/5 | In distribution | |
| DTR-020/100/5 | In distribution | |
| DTRH-017/80/6 | In distribution | |
| 467-005-TCH-S | In distribution | |
| 466-020/150/15 | In distribution | |
| DTR-020/54/10 | In distribution | |
| 466-018/100/10-BC | In distribution | |
| D466-015-TC | In distribution | |
| DHC-020/200/20 | In distribution | |
| DTRH-018/80/10 | In distribution | |
| 466-018/100/5-SC | In distribution | |
| 467-022/150/10-BC | In distribution | |
| DHC-022/50/2 | In distribution | |
| DHC-022/54/4 | In distribution | |
| 466-150-TC-S | In distribution | |
| DTR-018/200/10 | In distribution | |
| DTR-017/100/10 | In distribution | |
| DHC-022/54/5-SC | In distribution | |
| DTRH-017/100/6 | In distribution | |
| DHC-018/60/5-SC | In distribution | |
| DTR-017/150/6 | In distribution | |
| DHC-018/150/10-SC | In distribution | |
| DTRH-018/100/10 | In distribution | |
| DTRH-018/150/5 | In distribution | |
| 466-020/150/10-SC | In distribution | |
| DHC-020/150/10 | In distribution | |
| 467-022/150/10-B | In distribution | |
| 466-018/150/5 | In distribution | |
| 467-022/100/4-B | In distribution | |
| DHC-020/60/10-SC | In distribution | |
| 462-003-TCH-S | In distribution | |
| 466-020/150/5-SC | In distribution | |
| DHC-020/100/5-SC | In distribution | |
| DHC-023/200/5 | In distribution | |
| DTR-017/200/10 | In distribution | |
| 465-001-TC-S | In distribution | |
| 466-020/200/10 | In distribution | |
| DTRH-018/54/5 | In distribution | |
| DTRH-017/80/10 | In distribution | |
| D466-010 | In distribution | |
| 466-020/100/5-SC | In distribution | |
| 463-105-S | In distribution | |
| 467-022/50/5-SC | In distribution | |
| DHC-022/100/10-SC | In distribution | |
| 467-022/150/10-SC | In distribution | |
| 466-005-S | In distribution | |
| D466-015 | In distribution | |
| 466-020/54/10-SC | In distribution | |
| 467-022/150/5-BC | In distribution | |
| DHC-022/100/10 | In distribution | |
| DHC-016/100/6-SC | In distribution | |
| DHC-016/150/6-SC | In distribution | |
| DHC-022/150/10 | In distribution | |
| 466-004/150/10-BRC-S | In distribution | |
| 466-016/50/10-SC | In distribution | |
| 467-022/100/5-SC | In distribution | |
| DHC-022/54/2 | In distribution | |
| 466-020/60/5-B | In distribution | |
| 463-011-TCH-S | In distribution | |
| DHC-018/54/5 | In distribution | |
| DTRH-018/80/5 | In distribution | |
| DHC-020/50/10-SC | In distribution | |
| DHC-022/150/5-SC | In distribution | |
| 467-022/100/5-BC | In distribution | |
| 463-011-TC-S | In distribution | |
| DHC-020/150/15-SC | In distribution | |
| DHC-023/100/5 | In distribution | |
| DTR-018/54/10 | In distribution | |
| DHC-023/60/5 | In distribution | |
| DHC-022/50/5 | In distribution | |
| 466-003-15-S | In distribution | |
| D467-010-TC | In distribution | |
| 467-022/50/2 | In distribution | |
| 463-010-S | In distribution | |
| DHC-021/100/10 | In distribution | |
| 467-022/50/4 | In distribution | |
| 467-022/100/2-SC | In distribution | |
| 467-022/150/5-B | In distribution | |
| 466-018/200/10-SC | In distribution | |
| 467-022/54/2 | In distribution | |
| DHC-022/50/5-BC | In distribution | |
| DTRH-017/100/10 | In distribution | |
| DHC-020/150/2 | In distribution | |
| 466-016/150/6-SC | In distribution | |
| 463-010-TC-S | In distribution | |
| DHC-020/150/5 | In distribution | |
| 467-022/54/10 | In distribution | |
| DHC-016/150/10-SC | In distribution | |
| D466-015-TCH | In distribution | |
| 466-020-TC-S | In distribution | |
| DHC-022/150/10-BC | In distribution | |
| DHC-018/60/10-SC | In distribution | |
| 466-015-TCH-S | In distribution | |
| DTRH-017/200/6 | In distribution | |
| DHC-016/100/10 | In distribution | |
| 466-021/50/2 | In distribution | |
| 466-018/50/10-SC | In distribution | |
| DHC-022/50/10-SC | In distribution | |
| DXE-022/150/5 | In distribution | |
| 466-020/100/5-BC | In distribution | |
| 467-010-TCH-S | In distribution | |
| 466-004/150/5-R-S | In distribution | |
| 466-020/150/5 | In distribution | |
| DTR-018/150/10 | In distribution | |
| DHC-022/54/10-SC | In distribution | |
| 466-020-S | In distribution | |
| 466-015-S | In distribution | |
| DTR-020/54/5 | In distribution | |
| 462-100-S | In distribution | |
| 466-020/200/5 | In distribution | |
| DHC-016/100/6 | In distribution | |
| DTR-017/200/6 | In distribution | |
| 466-018/50/5-SC | In distribution | |
| DHC-016/50/10 | In distribution | |
| 467-022/200/10 | In distribution | |
| 462-004-S | In distribution | |
| DTRH-020/150/5 | In distribution | |
| 466-020/100/10-SC | In distribution | |
| DTRH-017/150/10 | In distribution | |
| 466-050-S | In distribution | |
| 465-002-TC-S | In distribution | |
| 466-200-S | In distribution | |
| 466-003-S | In distribution | |
| 467-005-TC-S | In distribution | |
| 466-020/100/15-SC | In distribution | |
| 467-022/54/4-B | In distribution | |
| 463-005-S | In distribution | |
| 467-050-TC-S | In distribution | |
| DHC-016/150/10 | In distribution | |
| 467-022/100/10-BC | In distribution | |
| 467-022/54/4 | In distribution | |
| 463-011-S | In distribution | |
| DXE-023/60/5 | In distribution | |
| DHC-021/50/4 | In distribution | |
| DHC-022/50/2-SC | In distribution | |
| DHC-020/200/10 | In distribution | |
| 466-018/100/10 | In distribution | |
| DST-023/60 | In distribution | |
| DHC-020/150/5-BC | In distribution | |
| 466-020/150/20-SC | In distribution | |
| 462-003-TC-S | In distribution | |
| DRC-022/100 | In distribution | |
| 467-022/50/10-SC | In distribution | |
| 466-016/100/10-SC | In distribution | |
| 467-022/50/5 | In distribution | |
| DHC-018/50/10-SC | In distribution | |
| DHC-018/150/5-SC | In distribution | |
| 466-018/150/10 | In distribution | |
| 466-018/150/10-BC | In distribution | |
| D466-020-TC | In distribution | |
| 466-020/54/5-BC | In distribution | |
| DHC-022/50/10 | In distribution | |
| 466-021/50/4 | In distribution | |
| DHC-022/54/4-SC | In distribution | |
| DTRH-020/150/10 | In distribution | |
| 463-002-S | In distribution | |
| 466-021/100/10-SC | In distribution | |
| 466-020/50/5-SC | In distribution | |
| DHC-023/150/5 | In distribution | |
| DTR-018/100/5 | In distribution | |
| 462-003-S | In distribution | |
| DHC-022/100/2 | In distribution | |
| DHC-022/60/5 | In distribution | |
| 466-020-TCH-S | In distribution | |
| 466-021/100/10 | In distribution | |
| DHC-022/54/4-B | In distribution | |
| DHC-018/100/10 | In distribution | |
| DHC-020/100/10 | In distribution | |
| DHC-022/150/10-B | In distribution | |
| 467-010-TC-S | In distribution | |
| 467-022/100/10-B | In distribution | |
| 466-021/100/5 | In distribution | |
| DHC-021/50/2 | In distribution | |
| 467-022/150/5 | In distribution | |
| 467-022/100/5-B | In distribution | |
| 466-020/150/2 | In distribution | |
| 467-022/50/4-SC | In distribution | |
| DHC-018/100/10-BC | In distribution | |
| D463-005 | In distribution | |
| DHC-020/100/5 | In distribution | |
| DRC-022/150 | In distribution | |
| DHC-018/50/5-SC | In distribution | |
| D467-010-TCH | In distribution | |
| 463-102-S | In distribution | |
| DTR-018/200/5 | In distribution | |
| DST-023/150 | In distribution | |
| DHC-022/60/10 | In distribution | |
| DHC-022/150/5-BC | In distribution | |
| DTR-018/100/10 | In distribution | |
| DXE-023/150/5 | In distribution | |
| 467-022/200/5 | In distribution | |
| 466-020/100/5 | In distribution | |
| 466-018/100/5-BC | In distribution | |
| 466-018/100/10-SC | In distribution | |
| 467-022/100/2 | In distribution | |
| 466-016/100/6-SC | In distribution | |
| DTRH-017/54/10 | In distribution | |
| DHC-020/200/5 | In distribution | |
| DHC-020/50/5 | In distribution | |
| DHC-018/150/5 | In distribution | |
| 467-022/150/10 | In distribution | |
| 466-020/150/15-SC | In distribution | |
| 466-020/100/10-BC | In distribution | |
| 463-014-S | In distribution | |
| 466-020/150/10-BC | In distribution | |
| 463-013-S | In distribution | |
| DHC-022/100/5-B | In distribution | |
| 467-022/50/5-BC | In distribution | |
| DHC-022/100/5 | In distribution | |
| 466-020/200/5-SC | In distribution | |
| 466-021/54/5-SC | In distribution | |
| DHC-016/50/6 | In distribution | |
| 467-100-TC-S | In distribution | |
| 466-015-TC-S | In distribution | |
| 466-020/150/10 | In distribution | |
| 462-004-TC-S | In distribution | |
| DTR-017/100/6 | In distribution | |
| 466-020/150/5-B | In distribution | |
| DTRH-020/80/5 | In distribution | |
| DHC-020/100/10-SC | In distribution | |
| 466-021/50/10 | In distribution | |
| DHC-018/200/10 | In distribution | |
| DTRH-020/54/5 | In distribution | |
| DHC-018/100/5 | In distribution | |
| DTRH-020/100/10 | In distribution | |
| 467-022/100/10 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Probe, Radiofrequency Lesion | Boston Scientific Neuromodulation Corporation | 175 |
| Halyard | Avanos Medical, Inc. | 156 |
| Lccs | Lccs Products Limited | 101 |
| Epimed | Epimed International, Inc. | 100 |
| Avanos | Avanos Medical, Inc. | 89 |
| NeuroTherm™ | Neurotherm, Inc. | 87 |
| Probe, Radiofrequency Lesion | St. Jude Medical | 66 |
| cannulaRFK | Cosman Medical, Inc. | 56 |
| Rftl | Pajunk Gmbh Medizintechnologie | 54 |
| Radiofrequency (RF) Needle | Spectra Medical Devices, LLC | 49 |
| cannulaCC | Cosman Medical, Inc. | 47 |
| Epimed | Minta Medical Limited | 35 |
Showing 12 of 85. All products under Probe, Radiofrequency Lesion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170708 | 2017-06-27 |
| K150371 | 2015-07-30 |
| K141586 | 2014-12-30 |
| K102566 | 2011-06-03 |
| K110593 | 2011-05-05 |
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.