DoseRite

Basic Information

• Brand Name: DoseRite
• Primary DI: 00850000610002
• Version / Model: DRJ05AT-6
• Catalog Number: DRJ05AT-6
• Company Name: SURGIN SURGICAL INSTRUMENTATION, INC.
• Labeler DUNS: 076656164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-10
• Public Version: 1
• Public Version Date: 2023-07-18
• Public Version Status: New
• Public Device Record Key: aecab091-58c7-4ce7-8197-1a077ce85cf2

Device Description

DoseRite Anal Fissure Pack, Reusable, Metric

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: 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
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	880.6960	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	00850000610002	GS1