FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Single use Surgical Optical Fiber
DI: 08033945937676
·
Model: OFH002011
·
QUANTA SYSTEM SPA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Single use Surgical Optical Fiber
- Primary DI
- 08033945937676
- Version / Model
- OFH002011
- Catalog Number
- EMP-FBX200HS
- Company Name
- QUANTA SYSTEM SPA
- Labeler DUNS
- 436045833
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-07
- Public Version
- 5
- Public Version Date
- 2022-08-25
- Public Version Status
- Update
- Public Device Record Key
- c7d3785d-3311-4818-a15a-f074b24054aa
- Distribution End Date
- 2022-08-24
Device Description
Single use Surgical Optical Fiber ø 200µm. Distributed by Olympus Surgical Technologies America. Gyrus ACMI, Inc.
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
- No
- 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 |
|---|---|---|---|---|
| 47785 | Urogenital surgical laser system beam guide, single-use | A flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, ureteral conditions (e.g., tumours, condylomas) or gynaecological disorders; it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08033945937690 | GS1 | carton box | 2 | Not in Commercial Distribution | 2022-08-24 |
| Package | 08033945937683 | GS1 | carton box | 5 | Not in Commercial Distribution | 2022-08-24 |
| Primary | 08033945937676 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180158 | 000 |