NeuroLine
- Primary DI
- 05999860261247
- Brand
- NeuroLine
- Company
- EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság
- Model
- NLO-9/13-1.5
- Catalog number
- NLO-9/13-1.5
- Device description
- Disposable Cranial Perforator
- Published
- 2025-09-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | Neurology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K213228 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05999860261247 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05999860261247 | 05999860261247 | 5999860261247 |
GMDN Terms#
| Term | Definition |
|---|---|
| Automatic cranial perforator, single-use | A sterile, metallic rotary endpiece designed to cut a circular section, or sections, of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It typically consists of two coaxial drill shafts (one rotating inside the other), a drive shank that enables connection to a powered (either electrical or pneumatic) handpiece, and a built-in clutch mechanism. The inner drill shaft extends slightly beyond the outer cutter in such a way that when the inner drill shafts penetrates the inner table of the skull the clutch mechanism disengages. This is a single-use device. |
Regulatory Flags#
- DUNS number
- 401383419
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 05999860261001 | NeuroLine | NLO-11/14-3.0 | NLO-11/14-3.0 | 2025-09-16 |
| 05999860261018 | NeuroLine | NLO-11/14-1.5 | NLO-11/14-1.5 | 2025-09-16 |
| 05999860261025 | NeuroLine | NLO-7/11-3.0 | NLO-7/11-3.0 | 2025-09-16 |
| 05999860261032 | NeuroLine | NLO-7/11-1.5 | NLO-7/11-1.5 | 2025-09-16 |
| 05999860261049 | NeuroLine | NLO-6/9-3.0 | NLO-6/9-3.0 | 2025-09-16 |
| 05999860261056 | NeuroLine | NLO-6/9-1.5 | NLO-6/9-1.5 | 2025-09-16 |
| 05999860261230 | NeuroLine | NLO-9/13-3.0 | NLO-9/13-3.0 | 2025-09-16 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 05999860261001 | NeuroLine | EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság | HBF | 2025-09-16 |
| 05999860261018 | NeuroLine | EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság | HBF | 2025-09-16 |
| 05999860261025 | NeuroLine | EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság | HBF | 2025-09-16 |
| 05999860261032 | NeuroLine | EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság | HBF | 2025-09-16 |
| 05999860261049 | NeuroLine | EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság | HBF | 2025-09-16 |
| 05999860261056 | NeuroLine | EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság | HBF | 2025-09-16 |
| 05999860261230 | NeuroLine | EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság | HBF | 2025-09-16 |
| 04054462020836 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462020850 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462020874 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462020898 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462020911 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462020935 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462020959 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462020973 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462122981 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462122998 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462123001 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462123018 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462123025 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462123032 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462123049 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 04054462123056 | Evonos | evonos GmbH & Co. KG | HBF | 2024-04-25 |
| 07898959543593 | EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm | Micromar Indústria e Comércio Ltda | HBF | 2023-10-30 |
| 07898959543609 | EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm | Micromar Indústria e Comércio Ltda | HBF | 2023-10-30 |
| 07898959543616 | EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm | Micromar Indústria e Comércio Ltda | HBF | 2023-10-30 |
| 07898959543623 | EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm | Micromar Indústria e Comércio Ltda | HBF | 2023-10-30 |
| 07898959543555 | EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm | Micromar Indústria e Comércio Ltda | HBF | 2022-12-02 |
| 07898959543562 | EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm | Micromar Indústria e Comércio Ltda | HBF | 2022-12-02 |
| 07898959543579 | EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm | Micromar Indústria e Comércio Ltda | HBF | 2022-12-02 |