MAXX LUXX LED
- Primary DI
- 0181587102157
- Brand
- MAXX LUXX LED
- Company
- D.R.E., INC.
- Model
- DRE SD2D2P4
- Device description
- DRE TRIO MAXX LUXX W/HD CAMERA
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| FST | Light, Surgical, Fiberoptic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FST | Light, Surgical, Fiberoptic | General, Plastic Surgery | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 0181587102157 | Package | GS1 | 1 | In Commercial Distribution |
| 00815871021579 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 0181587102157 | 00181587102157 | 181587102157 | 0181587102157 |
| 00815871021579 | 00815871021579 | 815871021579 | 0815871021579 |
GMDN Terms
| Term | Definition |
|---|---|
| Medical monitor/light mount | A permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 178440426
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 01815871021586 | MAXX LUXX LED | DRE SD2D2M1 | 2016-09-23 | |
| 01815871021593 | MAXX LUXX LED | DRE SD2D2VR | 2016-09-23 | |
| 01815871021609 | MAXX LUXX LED | DRE SD2D2D2 | 2016-09-23 | |
| 01815871021616 | MAXX LUXX LED | DRE SD2M1M1 | 2016-09-23 | |
| 01815871021623 | MAXX LUXX LED | DRE SD2SD2P3M1 | 2016-09-16 | |
| 01815871021630 | MAXX LUXX LED | DRE SD2D2P4M1 | 2016-09-23 | |
| 01815871021647 | VISION LED | DRE 061512 | 2016-09-23 | |
| 01815871021654 | VISION LED | DRE 061513 | 2016-09-23 | |
| 01815871021685 | VISION LED | DRE 061512-V | 2016-09-23 | |
| 01815871021692 | VISION LED | DRE 061513-V | 2016-09-23 | |
| 01815871021708 | VISION LED | DRE 061514-V | 2016-09-23 | |
| 01815871021715 | VISION LED | DRE 061515-V | 2016-09-23 | |
| 01815871021722 | VISION EX5 | DRE 061412 | 2016-09-23 | |
| 01815871021739 | VISION EX5 | DRE 061413 | 2016-09-23 | |
| 01815871021746 | VISION EX5 | DRE 061414 | 2016-09-23 | |
| 01815871021753 | VISION EX5 | DRE 061415 | 2016-09-23 | |
| 01815871021760 | VISION EX5 | DRE 061412-V | 2016-09-23 | |
| 01815871021777 | VISION EX5 | DRE 061413-V | 2016-09-23 | |
| 01815871021784 | VISION EX5 | DRE 061414-V | 2016-09-23 | |
| 01815871021791 | VISION EX5 | DRE 061415-V | 2016-09-23 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00816744020118 | NICO Myriad | NICO CORPORATION | FST | 2025-07-30 |
| 00816744021139 | NICO Myriad | NICO CORPORATION | FST | 2025-07-30 |
| 00816744021313 | NICO Myriad | NICO CORPORATION | FST | 2025-07-30 |
| 00816744021337 | NICO Myriad | NICO CORPORATION | FST | 2025-07-30 |
| 00816835024353 | Vu160 | Medical Illumination International Inc. | FST | 2025-02-19 |
| 01816835024369 | Vu160 | Medical Illumination International Inc. | FST | 2025-02-19 |
| 00816744020095 | NICO Myriad | NICO CORPORATION | FST | 2024-11-13 |
| 00816744020101 | NICO Myriad | NICO CORPORATION | FST | 2024-11-13 |
| 01816835024345 | SM1 | Medical Illumination International Inc. | FST | 2024-09-04 |
| 01816835024321 | MI-1000CAM | Medical Illumination International Inc. | FST | 2024-08-19 |
| 01816835024338 | MI-1000CAM | Medical Illumination International Inc. | FST | 2024-08-19 |
| 00840606184922 | Lucent Lateral | SPINAL ELEMENTS, INC. | FST | 2024-08-13 |
| 00840606184946 | Lucent Lateral | SPINAL ELEMENTS, INC. | FST | 2024-08-13 |
| 01816835024314 | SYSTEM TWO LED | Medical Illumination International Inc. | FST | 2024-01-18 |
| 01816835024307 | SYSTEM TWO LED | Medical Illumination International Inc. | FST | 2024-01-02 |
| 00195377048752 | NuVasive | Nuvasive, Inc. | FST | 2023-11-16 |
| 01816835024000 | IsoLED II LED HL (AC) | Medical Illumination International Inc. | FST | 2023-10-02 |
| 00816835024070 | 90 Deg Fiber Optic HL | Medical Illumination International Inc. | FST | 2023-10-02 |
| 01816835024086 | 90 Deg Fiber Optic HL | Medical Illumination International Inc. | FST | 2023-10-02 |
| 01816835024093 | 90 Deg Fiber Optic HL | Medical Illumination International Inc. | FST | 2023-10-02 |
| 01816835024109 | 90 Deg Fiber Optic HL | Medical Illumination International Inc. | FST | 2023-10-02 |
| 01816835024116 | 105 Deg Fiber Optic HL | Medical Illumination International Inc. | FST | 2023-10-02 |
| 01816835024123 | 105 Deg Fiber Optic HL | Medical Illumination International Inc. | FST | 2023-10-02 |
| 01816835024130 | 105 Deg Fiber Optic HL | Medical Illumination International Inc. | FST | 2023-10-02 |
| 01816835024147 | 105 Deg Fiber Optic HL | Medical Illumination International Inc. | FST | 2023-10-02 |
| 00888867353244 | Arthrex® | ARTHREX, INC. | FST | 2023-08-11 |
| 01816835023898 | Vu-E | Medical Illumination International Inc. | FST | 2022-12-09 |
| B382SD32000 | Surgical Direct | Surgical Direct, Inc. | FST | 2022-11-23 |
| 00816835023783 | SYSTEM TWO LED | Medical Illumination International Inc. | FST | 2022-10-12 |
| 00816835023776 | VistOR MS LED | Medical Illumination International Inc. | FST | 2022-10-07 |