| Primary Device ID | 04048223029770 |
| NIH Device Record Key | e3058481-f32a-41fc-b8ac-9a9e81cc28f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spinal Manometer NRFit |
| Version Model Number | 001163-38F |
| Catalog Number | 001163-38F |
| Company DUNS | 317654283 |
| Company Name | Pajunk GmbH Medizintechnologie |
| Device Count | 10 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| 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 |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048223029770 [Unit of Use] |
| GS1 | 04048223049860 [Primary] |
| GS1 | 14048223029777 [Primary] |
| FMJ | MANOMETER, SPINAL-FLUID |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-14 |
| Device Publish Date | 2020-07-06 |
| 04048223072622 - EPISPIN II | 2025-02-10 EpiSpin II Tuohy with backeye and wings 18G x 90cm, Sprotte Standard |
| 04048223075524 - TUOHY | 2025-02-10 TUOHY NANOLINE 22GX100 |
| 04048223043486 - UniPlex® NanoLine® | 2025-02-07 UniPlex® NanoLine® UP 3/50, 22G (0,70) x 50mm, with injection tube and connecting cable |
| 04048223045930 - Tuohy | 2025-02-07 Tuohy with spec. Point 18G x 3 1/2", metal stylet |
| 04048223048870 - Flat filter 0,2µm round | 2025-02-07 Flat filter 0,2µm round sterile |
| 04048223048887 - Injection Tube, LL male/LL female | 2025-02-07 Injection Tube, LL male/LL female plastic, total length 600mm, sterile |
| 04048223048955 - ClampingAdapter - white - | 2025-02-07 ClampingAdapter - white - steril |
| 04048223048986 - Spinal Manometer | 2025-02-07 Spinal Manometer with three-way cock |