Digisert

Basic Information

• Brand Name: Digisert
• Primary DI: 00840252905834
• Version / Model: 30511
• Catalog Number: 30511
• Company Name: Therafin Corporation
• Labeler DUNS: 056630924
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-06
• Public Version: 1
• Public Version Date: 2023-07-14
• Public Version Status: New
• Public Device Record Key: 89183653-6e18-411a-bde7-1de6eaed871e

Device Description

DIGI-SERT, EZ REACH

Device Characteristics

• Single Use: No
• 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: No
• Has Manufacturing Date: Yes
• 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
ILS	Adaptor, Hygiene	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60665	Rectal medication applicator, reusable	A non-sterile instrument intended to be inserted into the rectum for the application of medication to treat haemorrhoids or other conditions of the rectum/anus. It is typically a hollow, plastic device designed to be connected to a tube filled with a cream medication. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840252905834	GS1

Customer Contacts

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