FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: EOBN230031S0
·
Model: Dental Surgery Fiber 320µm
·
OBERON GmbH Fiber Technologies
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- EOBN230031S0
- Version / Model
- Dental Surgery Fiber 320µm
- 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
- 6
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- d8ab4c82-e413-4c16-8bf4-ae5945a81746
Device Description
Laser Surgery Fiber, core 320µm, clad 385µm, fiber OD 415µm, polyimide coating, standard SMA 905 connector with knurl nut, PVC protection cap, extension sleeve red engraved, black bend protection, Silicone tubing OD 2mm, distal flat tip, cleaved, 10cm freestanding fiber, NA 0.22, length 3m +/-0,2m, sterile EO, disposable, single 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 |
|---|---|---|---|---|
| 61474 | General/multiple surgical laser system beam guide, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EOBN230031S0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140470 | 000 |