FDA UDI
In Commercial Distribution
🇺🇸 United States
FiberTech®
DI: 04059497000136
·
Model: FT IR200/220PI-2.5/SMI-ES23 5K0CK1F
·
LEONI Fiber Optics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- FiberTech®
- Primary DI
- 04059497000136
- Version / Model
- FT IR200/220PI-2.5/SMI-ES23 5K0CK1F
- Catalog Number
- M270202S
- Company Name
- LEONI Fiber Optics GmbH
- Labeler DUNS
- 342703174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-29
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fdf46efd-1a0a-45a9-bf74-39d24dad122a
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|---|---|
| Package | 04059497000617 | GS1 | 2 | In Commercial Distribution | ||
| Package | 04059497000372 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 04059497000136 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K050738 | 000 |