FDA UDI
In Commercial Distribution
🇺🇸 United States
SurgiTouch™ Scanning Handpiece Set
DI: 07290117771396
·
Model: NA
·
LUMENIS BE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SurgiTouch™ Scanning Handpiece Set
- Primary DI
- 07290117771396
- Version / Model
- NA
- Company Name
- LUMENIS BE LTD
- Labeler DUNS
- 600763501
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-04
- Public Version
- 1
- Public Version Date
- 2023-12-12
- Public Version Status
- New
- Public Device Record Key
- 49a52255-f6a5-45df-b9c7-0cabb8c6472d
Device Description
Direct Marking (DM): 07290117771402, 07290117771426, 07290117771419, 07290117771952, 07290117771969, 07290117771976, 07290117771983, 07290117771990, 07290117772003, 07290117772010, 07290117772027, 07290117772034. . , ., ,
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63306 | Surgical laser system beam-focus handpiece | A noninvasive hand-held device intended to be connected to the beam guide of a surgical laser system to focus the laser beam during delivery to the target tissue. It is in the form of a rigid cylinder with integrated lenses which focus laser beam wavelengths for surgical applications. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290117771396 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212703 | 000 |