FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 20845854027438
·
Model: LG1090
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 20845854027438
- Version / Model
- LG1090
- Catalog Number
- LG1090
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2023-12-05
- Public Version Status
- Update
- Public Device Record Key
- f637782c-58fe-426b-99b0-c6c6906e2c33
- Distribution End Date
- 2023-12-04
Device Description
AUTOCLAVABLE 90 DEGREE TRANSLUCENT LIGHT GUIDE
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
- 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 |
|---|---|---|---|---|
| FST | LIGHT, SURGICAL, FIBEROPTIC | General, Plastic Surgery | 878.4580 | 2 |
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 | 30845854027435 | GS1 | ||||
| Primary | 20845854027438 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K901035 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3 | Meter | |
| Width | 5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY