| Primary Device ID | 04048223132241 | 
| NIH Device Record Key | dc90e911-3f58-440c-b9fa-5654ddf37620 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SonoPlex® II Facet NRFit | 
| Version Model Number | 001265-74 | 
| Catalog Number | 001265-74 | 
| Company DUNS | 317654283 | 
| Company Name | Pajunk GmbH Medizintechnologie | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | +1 770-493-6832 | 
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 | 
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 | 
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 | 
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 | 
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 | 
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 | 
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 | 
| info@pajunk-usa.com | 
| Length | 50 Millimeter | 
| Outer Diameter | 0.7 Millimeter | 
| Length | 50 Millimeter | 
| Outer Diameter | 0.7 Millimeter | 
| Length | 50 Millimeter | 
| Outer Diameter | 0.7 Millimeter | 
| Length | 50 Millimeter | 
| Outer Diameter | 0.7 Millimeter | 
| Length | 50 Millimeter | 
| Outer Diameter | 0.7 Millimeter | 
| Length | 50 Millimeter | 
| Outer Diameter | 0.7 Millimeter | 
| Length | 50 Millimeter | 
| Outer Diameter | 0.7 Millimeter | 
| Length | 50 Millimeter | 
| Outer Diameter | 0.7 Millimeter | 
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04048223051412 [Previous] | 
| GS1 | 04048223130865 [Primary] | 
| GS1 | 04048223132241 [Package] Contains: 04048223130865 Package: [10 Units] In Commercial Distribution  | 
| BSP | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2025-09-25 | 
| Device Publish Date | 2025-09-16 | 
| 04048223132296 | SonoPlex® II Facet NRFit 22G (0,70) x 80mm, with injection tube and connecting cable | 
| 04048223132289 | SonoPlex® II Facet NRFit 20G (0,90) x 150mm, with injection tube and connecting cable | 
| 04048223132197 | SonoPlex® II Facet NRFit 22G (0,70) x 40mm, with injection tube and connecting cable | 
| 04048223051429 | SonoPlex® II Facet NRFit 24G (0,55) x 30mm with injection tube and connecting cable | 
| 04048223132302 | SonoPlex® II Facet NRFit 20G (0,90) x 120mm with injection tube and connecting cable | 
| 04048223132319 | SonoPlex® II Facet NRFit 21G (0,80) x 100mm with injection tube and connecting cable | 
| 04048223132241 | SonoPlex® II Facet NRFit 22G (0,70) x 50mm, with injection tube and connecting cable | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() SONOPLEX  79294227  not registered Live/Pending  | 
        Pajunk GmbH Medizintechnologie  2020-07-02  | 
![]() SONOPLEX  72088340  0704513 Dead/Cancelled  | 
        SONNEBORN CHEMICAL AND REFINING CORPORATION  1959-12-31  |