GIGAA
- Primary DI
- 06977331780038
- Brand
- GIGAA
- Company
- Gigaalaser Company Ltd.
- Model
- GBOX-15AB
- Published
- 2024-11-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| NVK | Laser, Dental, Soft Tissue |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NVK | Laser, Dental, Soft Tissue | General, Plastic Surgery | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K230047 | 000 | Medical Diode Laser Systems | Gigaalaser Company , Ltd. | 2024-03-04 | NVK |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 06977331780038 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 06977331780038 | 06977331780038 | 6977331780038 |
GMDN Terms
| Term | Definition |
|---|
| Dental diode laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery. |
Regulatory Flags
- DUNS number
- 618495205
- 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
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 06977331780007 | GIGAA | Gigaalaser Company Ltd. | NVK | 2024-11-30 |
| 06977331780014 | GIGAA | Gigaalaser Company Ltd. | NVK | 2024-11-01 |
| 06977331780021 | GIGAA | Gigaalaser Company Ltd. | NVK | 2024-11-01 |
| 08059340290024 | Primo Dental Laser | MEDENCY SRL | NVK | 2024-04-10 |
| 10818365026453 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026463 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026470 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026494 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026500 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026517 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026524 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026548 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 10818365026552 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026562 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026579 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026586 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026593 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026609 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026623 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026630 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026647 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026654 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 10818365026668 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 10818365026675 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 10818365026682 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 10818365026699 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 10818365026705 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 10818365026712 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| 00818365026722 | EdgePRO™ | US ENDODONTICS, LLC | NVK | 2023-06-25 |
| E2352171B1 | DentaLaze Kit | SHOFU DENTAL CORPORATION | NVK | 2023-06-06 |