MONARCH DISPOSABLE ANOSCOPE

Basic Information

• Brand Name: MONARCH DISPOSABLE ANOSCOPE
• Primary DI: 00613970014856
• Version / Model: 1485C
• Catalog Number: 1485C
• Company Name: MONARCH MOLDING, INC.
• Labeler DUNS: 007136203
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 3
• Public Version Date: 2021-01-08
• Public Version Status: Update
• Public Device Record Key: 06130a79-8e8a-44b7-8ff6-5457161d6811

Device Description

ONE TIME USE 14mm x 85mm (CLEAR) PLASTIC DISPOSABLE ANOSCOPE 100/EACH PER CASE- 2/BAGS OF 50 EACH

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: 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
KDM	Sigmoidoscope, Rigid, Non-Electrical	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48081	Haemorrhoid electrotherapy system procedure kit	A collection of devices intended to be used in conjunction with a haemorrhoid management system to facilitate the procedure of electrically eliminating all grades of internal haemorrhoids. It typically includes a tissue contact electrode (a hand-held probe), a grounding pad sponge, and a disposable anoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613970014856	GS1
Unit of Use	10613970014853	GS1

Customer Contacts

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