FDA UDI
In Commercial Distribution
🇺🇸 United States
EQUATE
DI: 00681131080972
·
Model: SC-206
·
WAL-MART STORES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EQUATE
- Primary DI
- 00681131080972
- Version / Model
- SC-206
- 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
- 3d4c8d31-ca99-4e22-bbb7-6493dc0cb2c1
Device Description
Contact Lens Case,3 Pack FLAT BED SOAKING LENS CASE – 3 PACK. THESE CONTACT LENS CASES ARE MOLDED PLASTIC, FLAT STYLE CASES WITH SCREW TOP LIDS, SIMILAR IN DESIGN TO CURRENTLY MARKETED PRODUCTS. THE FLAT BED STYLE OF CONTACT LENS CASES ARE FOR STORAGE OF SOFT (HYDROPHYLLIC), RIGID GAS PERMEABLE (RGP), AND HARD CONTACT LENSES DURING CHEMICAL DISINFECTION.
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 |
|---|---|---|---|---|---|---|
| Primary | 00681131080972 | GS1 | ||||
| Package | 10681131080979 | GS1 | 3 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991206 | 000 |