FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Acculite EndoOto
DI: 07290109140841
·
Model: 24ga 10° Angled, SMA 905, 200µm
·
LUMENIS INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Acculite EndoOto
- Primary DI
- 07290109140841
- Version / Model
- 24ga 10° Angled, SMA 905, 200µm
- Company Name
- LUMENIS INC.
- Labeler DUNS
- 043618763
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 4
- Public Version Date
- 2020-02-24
- Public Version Status
- Update
- Public Device Record Key
- c6c8a999-eb0b-4d0e-b563-b4ac36c5cf32
- Distribution End Date
- 2020-02-21
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 61162 | Ophthalmic laser system beam guide | A sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290109140841 | GS1 | ||||
| Package | 17290109140848 | GS1 | 10 | Not in Commercial Distribution | 2020-02-21 |
Customer Contacts
- Phone
- 408-764-3000
- [email protected]