FDA UDI
In Commercial Distribution
🇺🇸 United States
Multi-Application Handpiece Set
DI: 07290109141534
·
Model: Multi-Application Handpiece Set
·
LUMENIS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Multi-Application Handpiece Set
- Primary DI
- 07290109141534
- Version / Model
- Multi-Application Handpiece Set
- Catalog Number
- AA2377300
- Company Name
- LUMENIS LTD.
- Labeler DUNS
- 600166524
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-28
- Public Version
- 6
- Public Version Date
- 2023-10-09
- Public Version Status
- Update
- Public Device Record Key
- 22e5ade8-052d-4032-9bec-798621e866e0
Device Description
Additional DM UDI: 07290109144146 07290109144153 07290109144160 07290109144016 07290109144184 07290109144191 07290109144207 07290109144214 07290109144221
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 | 07290109141534 | GS1 | ||||
| Direct Marking | 07290109144139 | GS1 |
Customer Contacts
- Phone
- 408-764-3000
- [email protected]