FDA UDI
In Commercial Distribution
🇺🇸 United States
AcuSpot 712 Micromanipulator
DI: 07290109141879
·
Model: AcuSpot 712 Micromanipulator
·
LUMENIS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AcuSpot 712 Micromanipulator
- Primary DI
- 07290109141879
- Version / Model
- AcuSpot 712 Micromanipulator
- Catalog Number
- AA2630000
- Company Name
- LUMENIS LTD.
- Labeler DUNS
- 600166524
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 7
- Public Version Date
- 2024-01-17
- Public Version Status
- Update
- Public Device Record Key
- b82ca5c1-3f2c-412e-b4cb-8d65da8556ab
Device Description
Additional DM DIs: 07290109144306 07290109144290
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 |
|---|---|---|---|---|
| 58210 | ENT surgery micromanipulator | A mains electricity (AC-powered) device designed for accurate manipulation of microscopic objects during ears/nose/throat (ENT) microsurgery (e.g., middle ear laser stapedotomy) usually by making small movements under the visual field of a surgical microscope. It includes precision motors that reproduce the movements of the hand on a microscopic scale (continuous or step-by-step movements performed with an input mechanism such as a joystick) applied to miniature tools which may be included (e.g., fine needles, small forceps). The device does not perform its actions following a computerized program. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290109141879 | GS1 | ||||
| Direct Marking | 07290109144313 | GS1 |
Customer Contacts
- Phone
- 408-764-3000
- [email protected]