FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Fiber Optic Cable
DI: 00812432020569
·
Model: 005776
·
LUMITEX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fiber Optic Cable
- Primary DI
- 00812432020569
- Version / Model
- 005776
- Catalog Number
- 48250215
- Company Name
- LUMITEX, INC.
- Labeler DUNS
- 108631797
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-04
- Public Version
- 4
- Public Version Date
- 2023-08-29
- Public Version Status
- Update
- Public Device Record Key
- 44e5763e-37b2-4aaa-8fe4-8f2d537a770a
- Distribution End Date
- 2023-08-11
Device Description
The LightMat Surgical Illuminator product family are supplied as sterile or non-sterile, single use, latex free, plastic fiber optic devices intended to bring cool area lighting into deep surgical sites. The LightMat is typically attached to various surgical retractors though use of adhesive strips and/or pre-applied adhesive backing. Some models of the LightMat also contain internal malleable members to provide moderate blunt retraction on its own.
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
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| FDG | Retractor, Fiberoptic | Gastroenterology, Urology | 876.4530 | 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 | 00812432020569 | GS1 |