DRILL DEPTH STOP CRANIAL 3.8
- Primary DI
- 04056481144388
- Brand
- DRILL DEPTH STOP CRANIAL 3.8
- Company
- Brainlab SE
- Model
- 56406-38
- Published
- 2022-08-30
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| HAW | Neurological Stereotaxic Instrument |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Neurology | 2 |
Premarket Submissions#
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K210989 | 000 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System | Brainlab AG | 2021-11-12 | HAW |
| K223864 | 000 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | Brainlab AG | 2023-09-09 | HAW |
| K243698 | 000 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | Brainlab AG | 2025-01-28 | HAW |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04056481144388 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04056481144388 | 04056481144388 | 4056481144388 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic implant/instrument depth limiter | An orthopaedic device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit or a reamer), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control the insertion depth; this can be to prevent the insertion of an instrument or implant below the surgical field of interest thereby avoiding damage to tissue behind or below the target structures. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 314482980
- Device count
- 1
- Serial number
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04056481147099 | Buzz O.R. Compute | 17922 | 2026-07-09 | |
| 04056481122751 | Sterilization Tray Standards Cranial Accessories | 52315 | 2020-10-21 | |
| 04056481122867 | Sterilization Tray Frameless Biopsy System | 52304 | 2020-10-21 | |
| 04056481122874 | Sterilization Tray Varioguide | 52303 | 2020-10-21 | |
| 04056481095406 | STERILIZATION TRAY SPINE BASIC/ANT/UNIV | 52306A | 52306A | 2020-04-02 |
| 04056481122812 | STERILIZATION TRAY HIP REPLACEMENT | 52309 | 52309 | 2020-04-02 |
| 04056481122904 | Sterilization Tray Trauma / Knee Arthroscopy | 52300 | 2020-01-31 | |
| 04056481122805 | Sterilization Tray Hip Resurfacing | 52310 | 52310 | 2019-09-27 |
| 04056481004835 | Em Sterilization Tray Basic Instruments | 18099-08A | 18099-08A | 2016-09-15 |
| 04056481002718 | Headband Reference Star - Connector | 41877-10 | 41877-10 | 2016-09-15 |
| 04056481003715 | Mscope Adapter Hs/Moeller Hi-R 700/1000 | 41767-85 | 41767-85 | 2016-09-15 |
| 04056481141363 | CRANIAL 4PI CT TABLE OVERLAY | 43430 | 2022-05-31 | |
| 04056481006884 | ELEMENTS LEAD LOCALIZATION | 1.0 | 26338-02 | 2016-11-18 |
| 04056481131920 | Registr. Matrix Imri Ge Headholder | 19202C | 19202C | 2016-09-17 |
| 04056481143985 | Mixed Reality Spine Navigation | 1.0 | 2025-05-31 | |
| 04056481144609 | ExacTrac Dynamic | 2.0 | 2025-02-19 | |
| 04056481144654 | Viewer 5.4 | 5.4 | 2024-11-05 | |
| 04056481004101 | Target Positioner Leksell | 40700-20A | 40700-20A | 2016-09-15 |
| 04056481006525 | Em Disposable Stylet | 18097 | 18097 | 2018-02-08 |
| 04056481138769 | Elements Trajectory Planning | 2.0 | 26250-02C | 2017-06-14 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 04719878691024 | Nao Trac S | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878691208 | Foot Controller | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878691246 | Display Screen | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878691307 | USB Mouse | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878691420 | Power Supply Cord | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878691468 | Power Supply Cord (US) 5m | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878692021 | Surgical Equipment Drape Packs | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878693004 | Reference Stylus | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878693042 | Tag S | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878693127 | Tag Support Arm | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878694001 | Instrument Registration Platform Cover | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695022 | Instrument Holder S | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695046 | Instrument Adaptor (3 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695060 | Instrument Adaptor (4 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695084 | Instrument Adaptor (5 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695107 | Instrument Adaptor (8 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695121 | SEEG Adaptor | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695145 | Catheter Adaptor | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695169 | Thumb Screw of Instrument Holder | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695183 | Set Screw of Instrument Holder | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695206 | Pin Screw of Instrument Adaptor | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695220 | Catheter Adaptor_3.5mm | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695244 | Instrument Adaptor (1.8 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695268 | Instrument Adaptor (2 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695282 | Instrument Adaptor (2.2 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695305 | Instrument Adaptor (2.5 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695329 | Instrument Adaptor (2.8 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695343 | Instrument Adator (3.2 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695367 | Instrument Adaptor (3.5 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695381 | Instrument Adaptor (4.6 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |