Sohn's Dilators SOD-03

GUDID 00861838000323

Dilators used for the treatment of anal fissure.

TOOLS FOR SURGERY, LLC

Rectal dilator, reusable
Primary Device ID00861838000323
NIH Device Record Key4486ddc4-0192-4996-9fea-b77eca2c73ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameSohn's Dilators
Version Model NumberSOD-03
Catalog NumberSOD-03
Company DUNS841842441
Company NameTOOLS FOR SURGERY, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6314444448
Emailinfo@toolsforsurgery.com

Device Dimensions

Outer Diameter30 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100861838000323 [Primary]

FDA Product Code

FFPDilator, Rectal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00861838000323]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-04
Device Publish Date2019-09-26