FDA UDI
In Commercial Distribution
🇺🇸 United States
Reusable Surgical Optical Fiber
DI: 08033945938499
·
Model: EMP-FBX365HR
·
QUANTA SYSTEM SPA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Reusable Surgical Optical Fiber
- Primary DI
- 08033945938499
- Version / Model
- EMP-FBX365HR
- Company Name
- QUANTA SYSTEM SPA
- Labeler DUNS
- 436045833
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-28
- Public Version
- 4
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- ed4c53ed-8446-4b77-94d8-047042f8042c
Device Description
Reusable 10x Surgical Optical Fiber ø 365 µm. Distributed by Olympus Surgical Technologies America. Gyrus ACMI, Inc.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization, Hydrogen Peroxide
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 |
|---|---|---|---|---|---|---|
| Package | 08033945938772 | GS1 | carton box | 2 | In Commercial Distribution | |
| Package | 08033945938635 | GS1 | carton box | 5 | In Commercial Distribution | |
| Primary | 08033945938499 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180158 | 000 |