| Primary Device ID | 14048223028794 |
| NIH Device Record Key | 8c04edf0-98de-4421-941c-eb0cbff33d8f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IntroDucer NRFit |
| Version Model Number | 021163-30L |
| Catalog Number | 021163-30L |
| Company DUNS | 317654283 |
| Company Name | Pajunk GmbH Medizintechnologie |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048223028797 [Unit of Use] |
| GS1 | 14048223028794 [Primary] |
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2018-06-12 |
| 14048223033897 | IntroDucer NRFit 1,0 x 40mm for the Standard SPROT |
| 14048223028800 | IntroDucer NRFit 1,0 x 30mm for the Standard SPROT |
| 14048223028794 | IntroDucer NRFit 0,8 x 30mm for the Standard SPROT |
| 04048223132173 | IntroDucer NRFit 1,0 x 40mm for the Standard SPROTTE® cannula 22G |
| 04048223132166 | IntroDucer NRFit 1,0 x 30mm for the Standard SPROTTE® NRFit 22G |
| 04048223129784 | IntroDucer NRFit 0,8 x 30mm for the Standard Sprotte Kanüle 24G/25G/26G/27G |
| 04048223053867 | IntroDucer NRFit 1,2 x 30mm for the Standard SPROTTE® NRFit 20G/21G |