FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: EOBN210136S0
·
Model: Fiber Optic for MRI yellow
·
OBERON GmbH Fiber Technologies
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- EOBN210136S0
- Version / Model
- Fiber Optic for MRI yellow
- Company Name
- OBERON GmbH Fiber Technologies
- Labeler DUNS
- 312889060
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-17
- Public Version
- 2
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 79b80556-c3ca-4bad-86c7-87c923f80032
Device Description
Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, black protection cap, extension sleeve silver, black PVC protection tube OD 1,5mm over 3m+/-0,1m on the proximal side, fiber stop yellow 235mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 10m +/-0,05m, 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
- MR Conditional
- 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 | EOBN210136S0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140470 | 000 |