SonoPlex® II NRFit 001265-31H
GUDID 04048223051368
SonoPlex® II NRFit with Sprotte tip 22G (0,70) x 70mm with injection tube and connecting cable
Pajunk GmbH Medizintechnologie
Nerve-locating anaesthesia needle| Primary Device ID | 04048223051368 |
| NIH Device Record Key | 1bf4a857-a5bd-4ffb-826e-0f26f27cd432 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SonoPlex® II NRFit |
| Version Model Number | 001265-31H |
| Catalog Number | 001265-31H |
| Company DUNS | 317654283 |
| Company Name | Pajunk GmbH Medizintechnologie |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
Customer Support Contacts
| 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 | |
| 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 |
Device Dimensions
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
| Length | 70 Millimeter |
| Needle Gauge | 22 Gauge |
Operating and Storage Conditions
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048223051368 [Package] Contains: 04048223071946 Package: [10 Units] In Commercial Distribution |
| GS1 | 04048223071946 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K243682
FDA Product Code
| BSP | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-23 |
| Device Publish Date | 2025-07-15 |
On-Brand Devices [SonoPlex® II NRFit]
| 04048223051375 | SonoPlex® II NRFit with Sprotte tip 22G (0,70) x 50mm with injection tube and connecting cable |
| 04048223051368 | SonoPlex® II NRFit with Sprotte tip 22G (0,70) x 70mm with injection tube and connecting cable |
| 04048223051351 | SonoPlex® II NRFit with Sprotte tip 22G (0,70) x 50mm with injection tube and connecting cable |
Trademark Results [SonoPlex]
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 |
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