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
LRX Case, Contact Lens

GMDN Terms

Code Name
16581 Contact lens case

Identifiers

Type ID
Primary 00681131080972
Package 10681131080979

Premarket Submissions

Submission Number Supplement Number
K991206 000