ALL SILICONE FOLEY BALLOON CATHETER

GUDID 08806369402606

2way/Translucent 30cc 24fr

Sewoon Medical Co., Ltd.

Indwelling urethral drainage balloon catheter, non-antimicrobial
Primary Device ID08806369402606
NIH Device Record Key26ecf8b5-f186-430c-a2bf-8a2bc851bd2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameALL SILICONE FOLEY BALLOON CATHETER
Version Model Number2102-024
Company DUNS687784405
Company NameSewoon Medical Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806369402606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZLCatheter, Retention Type, Balloon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-01
Device Publish Date2023-07-24

On-Brand Devices [ALL SILICONE FOLEY BALLOON CATHETER]

088063694036033way//Translucent 30cc 26fr
088063694031083way//Translucent 5cc 26fr
088063694030853way//Translucent 5cc 24fr
088063694030613way//Translucent 5cc 22fr
088063694030473way//Translucent 5cc 20fr
088063694030233way//Translucent 5cc 18fr
088063694030093way//Translucent 5cc 16fr
088063694026202way/Translucent 30cc 26fr
088063694026062way/Translucent 30cc 24fr
088063694025832way/Translucent 30cc 22fr
088063694025692way/Translucent 30cc 20fr
088063694025452way/Translucent 30cc 18fr
088063694025212way/Translucent 30cc 16fr
088063694025072way/Translucent 30cc 14fr
088063694020022way/Translucent 1.5cc 6fr
088063694006262way/Green 30cc 26fr
088063694006022way/Green 30cc 24fr
088063694005892way/Green 30cc 22fr
088063694005652way/Green 30cc 20fr
088063694005412way/Green 30cc 18fr
088063694005272way/Green 30cc 16fr
088063694005032way/Green 30cc 14fr
088063694000082way/Green 1.5cc 6fr

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