| Primary Device ID | 04048223048986 |
| NIH Device Record Key | 5fb660cd-7bbd-44d7-9677-93eebeb8ffab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spinal Manometer |
| Version Model Number | 001151-38G |
| Catalog Number | 001151-38G |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 04048223048986 [Package] Contains: 04048223069578 Package: [10 Units] In Commercial Distribution |
| GS1 | 04048223069578 [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 | 2025-02-07 |
| Device Publish Date | 2025-01-30 |
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| 04048223120323 - Filter | 2025-04-14 Filter 0,2µm, sterile |
| 04048223057650 - MonoBalloon DIL-XL | 2025-04-02 MonoBalloon DIL-XL Unilateral dilatation balloon Ø11mm round, Extra Large |
| 04048223057704 - MonoBalloon URO | 2025-04-02 MonoBalloon URO URO ring-anchor balloon Ø 11mm, for extraperitoneal surgery |
| 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 |