FDA UDI
In Commercial Distribution
🇺🇸 United States
Optisol
DI: 00757770601745
·
Model: 50006-OPT
·
Bausch & Lomb Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Optisol
- Primary DI
- 00757770601745
- Version / Model
- 50006-OPT
- Company Name
- Bausch & Lomb Incorporated
- Labeler DUNS
- 196603781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-04
- Public Version
- 3
- Public Version Date
- 2024-05-15
- Public Version Status
- Update
- Public Device Record Key
- 44576cbe-dc5f-4753-8d55-b934c2687fc9
Device Description
CORNEAL STORAGE MEDIA (Box of 12)
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
- Yes
- 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 |
|---|---|---|---|---|
| LYX | Media, Corneal Storage | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36094 | Corneal storage medium | A material used for storage and transport of harvested corneas prior to transplantation to the recipient. This material is intended to maintain the viability of the corneal tissue. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00757770601745 | GS1 |