Greenwald Surgical Company, Inc. U323

GUDID 10801334000134

Guyon Catheter Stylet. Stainless steel throughout, polished finish.

GRACE MANUFACTURING, INC.

Urethral dilator, reusable
Primary Device ID10801334000134
NIH Device Record Key1f2d7af8-bd05-4386-a1ea-c2a8a0ca2173
Commercial Distribution StatusIn Commercial Distribution
Brand NameGreenwald Surgical Company, Inc.
Version Model Number53230-06
Catalog NumberU323
Company DUNS607903382
Company NameGRACE MANUFACTURING, INC.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Gauge6 French

Device Identifiers

Device Issuing AgencyDevice ID
GS110801334000134 [Primary]

FDA Product Code

EZBStylet For Catheter, Gastro-Urology

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10801334000134]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-06
Device Publish Date2016-10-31

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