FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: EOBN270055S0
·
Model: Radial Emission Fiber 400µm
·
OBERON GmbH Fiber Technologies
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- EOBN270055S0
- Version / Model
- Radial Emission Fiber 400µm
- Company Name
- OBERON GmbH Fiber Technologies
- Labeler DUNS
- 312889060
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-18
- Public Version
- 7
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- fe1fdc99-7348-41b1-9d1d-6af87073070f
Device Description
Radial Emission Fiber, core 400µm, clad 420µm, fiber OD 950µm, white Vestodur Jacket with length marking, standard SMA905 connector with knurl nut, PVC protection cap, extension sleeve red engraved, black bend protection, LUER adapter, distal conical tip with silica capillary dome, capillary OD 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 | EOBN270055S0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140470 | 000 |