| Primary Device ID | 07340048304948 |
| NIH Device Record Key | eaca434c-3587-4bda-840c-aa8656dceb69 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leksell Stereotactic System Neurosurgical Instrume |
| Version Model Number | 1505535 |
| Company DUNS | 507772663 |
| Company Name | Elekta Instrument AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(855)693-5358 |
| info.america@elekta.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07340048304948 [Primary] |
| HAW | Neurological stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07340048304948]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2018-09-21 |
| 07340048311380 | NEEDLE WITH LUER LOCK |
| 07340048308656 | HAEMATOMA EVACUATOR 4.0 MM |
| 07340048308649 | LUER CONNECTION NEEDLE |
| 07340048308632 | INSERTION CANNULA 190/1.6 |
| 07340048308625 | CATHETHER INSERTION NEEDLE / 2.6 MM |
| 07340048308618 | CATH. INSERTION NEEDLE / 1.5 MM |
| 07340048308601 | SALCMAN TWIST DRILL 2.1/3.2 |
| 07340048308595 | SEDAN SIDE-CUTTING BIOPSY NEEDLE KIT 2 |
| 07340048308588 | SEDAN CUTTING NEEDLE 2.5 MM |
| 07340048308571 | TWIST DRILL 3.2 MM |
| 07340048308564 | TWIST DRILL 2.1 MM |
| 07340048308038 | DISPOSABLE STOP AND GUIDE |
| 07340048308014 | DISPOSABLE BIOPSY NEEDLE AND ASPIRATION TUBE |
| 07340048308007 | DISPOSABLE BIOPSY NEEDLE KIT |
| 07340048307833 | STYLET 0.9 MM |
| 07340048307819 | INJECTION/ASPIRATION NEEDLE KIT |
| 07340048307802 | STYLET 1.6 MM |
| 07340048307796 | CANNULA 2.1 MM |
| 07340048307772 | STYLET 1.9 |
| 07340048307765 | CANNULA 2.6 |
| 07340048307758 | INSERTION SLEEVE 3.5 |
| 07340048307727 | STYLET 0.9 MM |
| 07340048307710 | CANNULA 1.5 MM |
| 07340048307703 | INSERTION SLEEVE 2.1 MM |
| 07340048307680 | ADJUSTABLE / STOP 3.2 MM |
| 07340048307673 | ADJUSTABLE / STOP 2.1 MM |
| 07340048307666 | REDUCING TUBE |
| 07340048307659 | DRILL SLEEVE LONG |
| 07340048307642 | DRILL SLEEVE 4 MM |
| 07340048307635 | TWIST DRIL 3.2 MM |
| 07340048307628 | TWIST DRILL 2.1 MM |
| 07340048307604 | INNER CANNULA D=1,5 BIOPSY L=5 |
| 07340048307598 | OUTER CANNULA D=2.1 BIOPSY L=5 ASM |
| 07340048307574 | SEDAN SIDE-CUTTING BIOPSY NEEDLE KIT 2 |
| 07340048307567 | INNER CANNULA D=2.0 BIOPSY L=10 |
| 07340048307550 | OUTER CANNULA D=2.5 L=10 |
| 07340048304948 | STOP WITH 1.5 MM HOLE |
| 07340048304931 | GUIDE WITH 1.5 MM HOLE |
| 07340048302708 | GUIDE WITH 6.0 MM HOLE |
| 07340048302692 | GUIDE WITH 4.0 MM HOLE |
| 07340048302685 | GUIDE WITH 3.5 MM HOLE |
| 07340048302678 | GUIDE WITH 3.2 MM HOLE |
| 07340048302661 | GUIDE WITH 2.5 MM HOLE |
| 07340048302654 | GUIDE WITH 2.1 MM HOLE |
| 07340048302630 | STOP WITH 6.0 MM HOLE |
| 07340048302623 | STOP WITH 4.0 MM HOLE |
| 07340048302616 | STOP WITH 3.5 MM HOLE |
| 07340048302609 | STOP WITH 3.2 MM HOLE |
| 07340048302593 | STOP WITH 2.5 MM HOLE |
| 07340048302586 | STOP WITH 2.1 MM HOLE |