FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AcuPulse™ Incisional Handpiece 125 mm
DI: 07290109141527
·
Model: AcuPulse™ Incisional Handpiece 125 mm
·
LUMENIS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AcuPulse™ Incisional Handpiece 125 mm
- Primary DI
- 07290109141527
- Version / Model
- AcuPulse™ Incisional Handpiece 125 mm
- Catalog Number
- AA0632600
- Company Name
- LUMENIS LTD.
- Labeler DUNS
- 600166524
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-28
- Public Version
- 6
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 6c2964c5-b10d-43f7-b49c-4f56a798201a
- Distribution End Date
- 2023-12-04
Device Description
Additional DM DIs: 07290109144016 07290109144023 07290109144030
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 | 07290109141527 | GS1 | ||||
| Direct Marking | 07290109144009 | GS1 |
Customer Contacts
- Phone
- 408-764-3000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 125 | Millimeter |