| Primary Device ID | 04048223111512 |
| NIH Device Record Key | afc084e6-9c47-4015-aff1-4865448c1691 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FLOW TAP |
| Version Model Number | 1280-03WR |
| Catalog Number | 1280-03WR |
| Company DUNS | 317654283 |
| Company Name | Pajunk GmbH Medizintechnologie |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048223111512 [Primary] |
| KOA | SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-19 |
| Device Publish Date | 2021-07-09 |
| 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 |