Flents

Basic Information

• Brand Name: Flents
• Primary DI: 00025715696263
• Version / Model: 69626
• Company Name: APOTHECARY PRODUCTS, LLC
• Labeler DUNS: 092312735
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2020-09-10
• Public Version: 1
• Public Version Date: 2020-09-18
• Public Version Status: New
• Public Device Record Key: b81a8ce1-2b77-4e23-946e-ffca8440200a

Device Description

FINGER COVERS-ASST 6/72

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
Unit of Use	40025715696261	GS1
Primary	00025715696263	GS1
Package	20025715696267	GS1	bag	6	In Commercial Distribution
Package	10025715696260	GS1	case	12	In Commercial Distribution

Customer Contacts

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