Sohn's Dilators

Basic Information

• Brand Name: Sohn's Dilators
• Primary DI: 00861838000323
• Version / Model: SOD-03
• Catalog Number: SOD-03
• Company Name: TOOLS FOR SURGERY, LLC
• Labeler DUNS: 841842441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-26
• Public Version: 1
• Public Version Date: 2019-10-04
• Public Version Status: New
• Public Device Record Key: 4486ddc4-0192-4996-9fea-b77eca2c73ba

Device Description

Dilators used for the treatment of anal fissure.

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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFP	Dilator, Rectal	Gastroenterology, Urology	876.5450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11262	Rectal dilator, reusable	A surgical instrument designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00861838000323	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	40	Millimeter
Outer Diameter	35	Millimeter
Outer Diameter	30	Millimeter