Equate

Basic Information

• Brand Name: Equate
• Primary DI: 00681131161763
• Version / Model: 557642344 (F414-436WM)
• Company Name: WAL-MART STORES, INC.
• Labeler DUNS: 051957769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 36
• Record Status: Published
• Publish Date: 2020-09-16
• Public Version: 1
• Public Version Date: 2020-09-24
• Public Version Status: New
• Public Device Record Key: d3fd9f4d-dae4-41c3-abe2-33e563dcd662

Device Description

Equate Finger Covers

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31978	Finger-cot surgical drape	A protective covering made of latex designed to isolate a urological/gynaecological surgical site from contamination (e.g., microbial, substance), that has a projection (finger cot) retained within the rectum or vagina to allow repeated insertion of the surgeon's finger into the rectum (e.g., during a transurethral prostatectomy) or vagina, keeping the glove of the surgeon from being contaminated. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20681131161767	GS1	inner	6	In Commercial Distribution
Primary	00681131161763	GS1
Package	10681131161760	GS1	case	4	In Commercial Distribution
Unit of Use	40023185144367	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]