SonoTAP® NRFit 1196-4K090
GUDID 04048223126219
SonoTAP® NRFit Tuohy 18G x 90mm with Injection tube, sterile
Pajunk GmbH Medizintechnologie
Peripheral nerve-block sharp needle| Primary Device ID | 04048223126219 |
| NIH Device Record Key | 83654f4f-e748-458b-b335-8e286f2fec9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SonoTAP® NRFit |
| Version Model Number | 1196-4K090 |
| Catalog Number | 1196-4K090 |
| 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 |
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 | |
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com |
Device Dimensions
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 90 Millimeter |
| Needle Gauge | 18 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 |
| 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 | 04048223126196 [Primary] |
| GS1 | 04048223126219 [Package] Contains: 04048223126196 Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K243525
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 | 2025-07-07 |
| Device Publish Date | 2025-06-27 |
Devices Manufactured by Pajunk GmbH Medizintechnologie
| 04048223128817 - SPROTTE® | 2025-09-25 SPROTTE® 25G x 3 1/2" (90mm) with magnification and Introducer, sterile |
| 04048223129111 - SPROTTE® NRFit | 2025-09-25 SPROTTE® NRFit 25G x 4 3/4" (120mm) with magnification and IntroDucer NRFit 40mm, sterile |
| 04048223129517 - SPROTTE® NRFit | 2025-09-25 SPROTTE® NRFit 25G x 4" (103mm) with magnification and IntroDucer NRFit 40mm, sterile |
| 04048223129647 - SPROTTE® | 2025-09-25 SPROTTE® 22G x 2" (50mm), sterile |
| 04048223129678 - SPROTTE® NRFit | 2025-09-25 SPROTTE® NRFit 22G x 3 1/2" (90mm) with magnification and IntroDucer NRFit 30mm, sterile |
| 04048223129692 - SPROTTE® NRFit | 2025-09-25 SPROTTE® NRFit 27G x 4 3/4" (120mm) with magnification and IntroDucer NRFit 40mm, sterile |
| 04048223129838 - SPROTTE® NRFit | 2025-09-25 SPROTTE® NRFit 25G x 6" (150mm) with magnification and IntroDucer NRFit 40mm, sterile |
| 04048223129999 - Standard Sprotte Needle | 2025-09-25 Standard Sprotte Needle 25G x 3 1/2" (90mm), sterile with Introducer and wings |
Trademark Results [SonoTAP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONOTAP 79294224 not registered Live/Pending |
Pajunk GmbH Medizintechnologie 2020-07-02 |
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