SPROTTE® NRFit 001163-29E
GUDID 04048223132159
SPROTTE® NRFit 25G x 1 3/8" (35mm)
Pajunk GmbH Medizintechnologie
Spinal needle, single-use| Primary Device ID | 04048223132159 |
| NIH Device Record Key | c8197a35-fb64-4ac9-8b80-32e80e0277ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPROTTE® NRFit |
| Version Model Number | 001163-29E |
| Catalog Number | 001163-29E |
| 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 | |
| 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 | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 0.5 Millimeter |
Operating and Storage Conditions
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048223049730 [Previous] |
| GS1 | 04048223130773 [Primary] |
| GS1 | 04048223132159 [Package] Contains: 04048223130773 Package: [25 Units] In Commercial Distribution |
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 | 2025-06-25 |
| Device Publish Date | 2025-06-17 |
On-Brand Devices [SPROTTE® NRFit]
| 14048223031657 | SPROTTE® NRFit 24G x 1 3/8" (35mm) sterile |
| 14048223030353 | SPROTTE® NRFit 27G x 4 ¾" (120mm) with IntroDu |
| 14048223030346 | SPROTTE® NRFit 27G x 3 ½" (90mm), with IntroDu |
| 14048223030339 | SPROTTE® NRFit 25G x 6" (150mm) |
| 14048223030315 | SPROTTE® NRFit 25G x 3 ½" (90mm), with IntroDu |
| 14048223030308 | SPROTTE® NRFit 24G x 8" (200mm) with IntroDuc |
| 14048223030292 | SPROTTE® NRFit 24G x 1" (25mm) |
| 14048223030261 | SPROTTE® NRFit 22G x 4" (103mm) with IntroDuc |
| 14048223030254 | SPROTTE® NRFit 22G x 3½" (90mm) |
| 14048223029913 | SPROTTE® NRFit 27G x 3 ½" (90mm) with IntroDu |
| 14048223029821 | SPROTTE® NRFit 24G x 3½" (90mm) |
| 14048223027025 | SPROTTE® NRFit 27G x 4 ¾" (120mm) |
| 14048223027018 | SPROTTE® NRFit 27G x 4" (103mm) with IntroDuc |
| 14048223027001 | SPROTTE® NRFit 25G x 6" (150mm) with IntroDuc |
| 14048223026998 | SPROTTE® NRFit 25G x 4 ¾" (120mm) |
| 14048223026981 | SPROTTE® NRFit 25G x 4 ¾" (120mm) with IntroDu |
| 14048223026974 | SPROTTE® NRFit 25G x 4" (103mm) with IntroDuc |
| 14048223026967 | SPROTTE® NRFit 25G x 3 ½" (90mm) |
| 14048223026950 | SPROTTE® NRFit 25G x 3 ½" (90mm) with IntroDu |
| 14048223026943 | SPROTTE® NRFit 25G x 1 3/8" (35mm) |
| 14048223026936 | SPROTTE® NRFit 24G x 6" (150mm) with IntroDuc |
| 14048223026929 | SPROTTE® NRFit 24G x 4 ¾" (120mm) with IntroDu |
| 14048223026912 | SPROTTE® NRFit 24G x 4" (103mm) with IntroDuc |
| 14048223026905 | SPROTTE® NRFit 24G x 3 ½" (90mm) with IntroDu |
| 14048223026899 | SPROTTE® NRFit 22G x 6" (150mm) with IntroDuc |
| 14048223026882 | SPROTTE® NRFit 22G x 4 ¾" (120mm) with IntroDu |
| 14048223026875 | SPROTTE® NRFit 22G x 3 ½" (90mm) with IntroDu |
| 04048223066546 | SPROTTE® NRFit 20G x 3 1/2" (90mm), with IntroDucer NRFit 30mm and wing |
| 04048223128114 | SPROTTE® NRFit 24G x 3 1/2" (90mm) with magnification and IntroDucer NRFit 30mm, sterile |
| 04048223132159 | SPROTTE® NRFit 25G x 1 3/8" (35mm) |
| 04048223132142 | SPROTTE® NRFit 24G x 31/2" (90mm) with magnification sterile |
| 04048223132104 | SPROTTE® NRFit 24G x 1 3/8" (35mm) sterile |
| 04048223132081 | SPROTTE® NRFit 22G x 31/2" (90mm) with magnification sterile |
| 04048223129777 | SPROTTE® NRFit 24G x 4" (103mm) with IntroDucer NRFit 40mm |
| 04048223129715 | SPROTTE® NRFit 27G x 3 1/2" (90mm) with magnification and IntroDucer NRFit 30mm, sterile |
| 04048223129630 | SPROTTE® NRFit 24G x 6" (150mm) with IntroDucer NRFit 40mm |
| 04048223129524 | SPROTTE® NRFit 24G x 4 3/4" (120mm) with IntroDucer NRFit 40mm |
| 04048223129463 | SPROTTE® NRFit 22G x 6" (150mm) with magnification and IntroDucer NRFit 40mm, sterile |
| 04048223129326 | SPROTTE® NRFit 22G x 4 3/4" (120mm) with magnification and IntroDucer NRFit 40mm, sterile |
| 04048223129302 | SPROTTE® NRFit 27G x 4" (103mm) with magnification and IntroDucer NRFit 40mm, sterile |
| 04048223129180 | SPROTTE® NRFit 27G x 3 1/2" (90mm), with IntroDucer NRFit 40mm |
| 04048223129159 | SPROTTE® NRFit 22G x 4" (103mm) with IntroDucer NRFit 40mm |
| 04048223129005 | SPROTTE® NRFit 21G x 31/2" (90mm), with IntroDucer NRFit 30mm and wing |
Trademark Results [SPROTTE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPROTTE 74257948 1741126 Live/Registered |
Pajunk GmbH 1992-03-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.