FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: EOBN270118S0
·
Model: Laser Surgery Fiber - Radial Emission Fiber 400µm Vein
·
OBERON GmbH Fiber Technologies
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- EOBN270118S0
- Version / Model
- Laser Surgery Fiber - Radial Emission Fiber 400µm Vein
- Company Name
- OBERON GmbH Fiber Technologies
- Labeler DUNS
- 312889060
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-15
- Public Version
- 3
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 720707f1-05fd-4f49-baab-a1f660044f62
Device Description
Radial Emission Fiber Vein, core 400µm, clad 420µm, fiber OD 900µm, white Tefzel Jacket with length marking, SMA 905 connector, PVC protection cap, RFID extension sleeve red, black bend protection, distal conical tip with silica capillary dome 1000µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed
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 |
|---|---|---|---|---|
| 62600 | General/multiple surgical laser system beam guide, single-use | A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EOBN270118S0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140470 | 000 |