| 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 |