Leksell Stereotactic System
GUDID 07340201502648
FIXATION SCREW 27,5 MM, TITANIUM
Elekta Solutions AB
Neurological stereotactic surgery system| Primary Device ID | 07340201502648 |
| NIH Device Record Key | e601afff-8398-4291-9a1f-fe6511606d11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leksell Stereotactic System |
| Version Model Number | 1040336 |
| Company DUNS | 353272181 |
| Company Name | Elekta Solutions AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com | |
| Phone | +1(855)693-5358 |
| info.america@elekta.com |
Device Dimensions
| Length | 27.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 27.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 27.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 27.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 27.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 27.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 27.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 27.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 27.5 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07340201502648 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152558
FDA Product Code
| HAW | Neurological stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07340201502648]
Moist Heat or Steam Sterilization
[07340201502648]
Moist Heat or Steam Sterilization
[07340201502648]
Moist Heat or Steam Sterilization
[07340201502648]
Moist Heat or Steam Sterilization
[07340201502648]
Moist Heat or Steam Sterilization
[07340201502648]
Moist Heat or Steam Sterilization
[07340201502648]
Moist Heat or Steam Sterilization
[07340201502648]
Moist Heat or Steam Sterilization
[07340201502648]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-15 |
| Device Publish Date | 2025-08-07 |
On-Brand Devices [Leksell Stereotactic System]
| 07340201502334 | DISPOSABLE INSERTS 4 PCS |
| 07340201502341 | OPEN MR-INDICATOR |
| 07340201503263 | FRAME G |
| 07340201502297 | STERILIZING TRAY FOR G FRAME KIT |
| 07340201502884 | LEKSELL STEREOTACTIC SYSTEM CLAMP, Frame support, ingoing part of 1040304. |
| 07340201502877 | LEKSELL STEREOTACTIC SYSTEM CLAMP, Clamp Spacer, ingoing part of 1040304. |
| 07340201502860 | LEKSELL STEREOTACTIC SYSTEM CLAMP, Headrest support, ingoing part of 1040304. |
| 07340201502280 | LEKSELL STEREOTACTIC SYSTEM CLAMP |
| 07340201503478 | TITANIUM FIXATION SCREW, KIT 5 PAIRS |
| 07340201502693 | FIXATION SCREW 40 MM, TITANIUM |
| 07340201502648 | FIXATION SCREW 27,5 MM, TITANIUM |
| 07340201502716 | FIXATION SCREW 45 MM, TITANIUM |
| 07340201502624 | FIXATION SCREW 22,5 MM, TITANIUM |
| 07340201502983 | STERILIZING TRAY FOR MULTIPURPOSE ARC |
| 07340201502907 | Post Insulated posterior short |
| 07340201502754 | FIXATION SCREW 65 MM, TITANIUM |
| 07340201502655 | FIXATION SCREW 30 MM, TITANIUM |
| 07340201502631 | FIXATION SCREW 25 MM, TITANIUM |
| 07340201502600 | FIXATION SCREW 20 MM, TITANIUM |
| 07340201502815 | Sterilization Case Fixation Screws |
| 07340201502662 | FIXATION SCREW 32,5 MM, TITANIUM |
| 07340201503492 | TITANIUM FIXATION SCREW, KIT 20 PAIRS |
| 07340201502808 | FIXATION SCREW 110 MM, TITANIUM |
| 07340201502792 | FIXATION SCREW 90 MM, TITANIUM |
| 07340201502785 | FIXATION SCREW 80 MM, TITANIUM |
| 07340201502778 | FIXATION SCREW 75 MM, TITANIUM |
| 07340201502761 | FIXATION SCREW 70 MM, TITANIUM |
| 07340201502747 | FIXATION SCREW 60 MM, TITANIUM |
| 07340201502730 | FIXATION SCREW 55 MM, TITANIUM |
| 07340201502723 | FIXATION SCREW 50 MM, TITANIUM |
| 07340201502709 | FIXATION SCREW 42,5 MM, TITANIUM |
| 07340201502686 | FIXATION SCREW 37,5 MM, TITANIUM |
| 07340201503126 | OPEN MR-INDICATOR - PLATE LEFT |
| 07340201502969 | OPEN MR-INDICATOR - PLATE HOLDER |
| 07340201502952 | OPEN MR-INDICATOR - PLATE RIGHT |
| 07340201502617 | CT-Adapter, Adjustable |
| 07340201502327 | CROSS HAIR TARGET, STAINLESS - ingoing part CROSS HAIR TARGET CROSS |
| 07340201502310 | CROSS HAIR TARGET, STAINLESS - ingoing part CROSS HAIR TARGET RING |
| 07340201502303 | CROSS HAIR TARGET, STAINLESS |
Trademark Results [Leksell Stereotactic System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LEKSELL STEREOTACTIC SYSTEM 75257621 not registered Dead/Abandoned |
Elekta AB 1997-03-13 |
 LEKSELL STEREOTACTIC SYSTEM 73391725 not registered Dead/Abandoned |
AKTIEBOLAGET ELEKTA-INSTRUMENT 1982-09-29 |
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