FDA UDI
In Commercial Distribution
🇺🇸 United States
Optego
DI: 00360843008602
·
Model: 938507-SF
·
Optego Vision USA Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Optego
- Primary DI
- 00360843008602
- Version / Model
- 938507-SF
- Company Name
- Optego Vision USA Inc.
- Labeler DUNS
- 835541145
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2023-08-23
- Public Version
- 1
- Public Version Date
- 2023-08-31
- Public Version Status
- New
- Public Device Record Key
- 6fa5f302-b096-4bfc-a999-1c9dbf7056d6
Device Description
Contact Lens Cases, White, 12/pk
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
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRX | Case, Contact Lens | Ophthalmic | 886.5928 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16581 | Contact lens case | A container, typically made of plastic, designed for the storage of contact lenses when the lenses are not being used by the owner. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00360843008961 | GS1 | ||||
| Primary | 00360843008602 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112832 | 000 |