FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FUSION-DESIGN
DI: 04055207026274
·
Model: 80661618
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FUSION-DESIGN
- Primary DI
- 04055207026274
- Version / Model
- 80661618
- Catalog Number
- 80661618
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 7
- Public Version Date
- 2024-02-29
- Public Version Status
- Update
- Public Device Record Key
- dc1f60e0-52bd-4a32-bb8e-02f886f818e1
- Distribution End Date
- 2024-01-01
Device Description
FIBER LIGHT CABLE Ø 1.6MM TL 1.8M color code blue
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FEM | ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35507 | Fibreoptic light cable | A flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207026274 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1.8 | Meter | |
| Outer Diameter | 1.6 | Millimeter |