Medline

Basic Information

• Brand Name: Medline
• Primary DI: 20193489104858
• Version / Model: FMDIS01
• Catalog Number: FMDIS01
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2024-04-25
• Public Version: 1
• Public Version Date: 2024-05-03
• Public Version Status: New
• Public Device Record Key: 6334d779-e7a4-4dc8-b172-a8beda4a9bfa

Device Description

DISIMPACTOR, FECAL IMPACTION, MEDLINE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
FHB	HOOK, GASTRO-UROLOGY	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64022	Soft-tissue surgical hook, single-use	A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30193489104855	GS1	BX	5	In Commercial Distribution
Primary	20193489104858	GS1
Unit of Use	10193489104851	GS1

Customer Contacts

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