FDA UDI
In Commercial Distribution
🇺🇸 United States
EQUATE
DI: 00681131248914
·
Model: SC-110
·
WAL-MART STORES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EQUATE
- Primary DI
- 00681131248914
- Version / Model
- SC-110
- Company Name
- WAL-MART STORES, INC.
- Labeler DUNS
- 051957769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-02
- Public Version
- 1
- Public Version Date
- 2018-11-02
- Public Version Status
- New
- Public Device Record Key
- 3d6281b9-7880-4515-bd99-c20f64f57ad6
Device Description
FLIP TOP CONTACT LENS CASE, 1 PACK
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 10681131248911 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00681131248914 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991206 | 000 |