| Primary Device ID | 14048223016081 |
| NIH Device Record Key | 551de4ac-fdce-44c1-bb19-cf093a77ea1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClampingAdapter - red - |
| Version Model Number | 001151-37U |
| Catalog Number | 001151-37U |
| 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 |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048223016084 [Unit of Use] |
| GS1 | 14048223016081 [Primary] |
| BSO | CATHETER, CONDUCTION, ANESTHETIC |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-08-09 |
| Device Publish Date | 2018-05-22 |
| 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 |