FDA UDI
In Commercial Distribution
🇺🇸 United States
Fiberoptic Light Port
DI: 10840199516015
·
Model: 7332-64
·
KOROS U.S.A., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Fiberoptic Light Port
- Primary DI
- 10840199516015
- Version / Model
- 7332-64
- Catalog Number
- 7332-64
- Company Name
- KOROS U.S.A., INC.
- Labeler DUNS
- 007928633
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-31
- Public Version
- 1
- Public Version Date
- 2025-01-08
- Public Version Status
- New
- Public Device Record Key
- 134f1042-698e-4633-b1fa-29833b42492d
Device Description
Alif Deep Fiberoptic Light Port 16cm
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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| EQH | Source, Carrier, Fiberoptic Light | Ear, Nose, Throat | 874.4350 | 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 |
|---|---|---|---|---|---|---|
| Direct Marking | 00840199516018 | GS1 | ||||
| Primary | 10840199516015 | GS1 |
Customer Contacts
- Phone
- 1-805-529-0825
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry place at room temperature