Soehendra SBDC-8.5

GUDID 00827002220621

Soehendra Biliary Dilation Catheter

COOK INCORPORATED

Biliary drainage catheter
Primary Device ID00827002220621
NIH Device Record Key9d20ad75-42d2-499e-b1a7-b743a696c66f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoehendra
Version Model NumberG22062
Catalog NumberSBDC-8.5
Company DUNS079720472
Company NameCOOK INCORPORATED
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(812)330-5494
Emailsharedservices@cookmedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100827002220621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGEStents, drains and dilators for the biliary ducts

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-20
Device Publish Date2018-06-19

On-Brand Devices [Soehendra]

00827002508002Soehendra Biliary Dilation Catheter
00827002222052Soehendra Stent Retriever
00827002220621Soehendra Biliary Dilation Catheter
00827002220461Soehendra Biliary Dilation Catheter
00827002219373Soehendra Stent Retriever
00827002219342Soehendra Stent Retriever
00827002218604Soehendra Lithotriptor Handle
00827002217324Soehendra Billroth II Sphincterotome
00827002217294Soehendra Biliary Dilation Catheter
00827002216617Soehendra Stent Retriever
00827002216044Soehendra Lithotripsy Cable
00827002215764Soehendra Biliary Dilation Catheter
00827002215733Soehendra Biliary Dilation Catheter
00827002215719Soehendra Biliary Dilation Catheter
00827002215689Soehendra Biliary Dilation Catheter
00827002215351Soehendra Stent Retriever

Trademark Results [Soehendra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOEHENDRA
SOEHENDRA
74232968 1800616 Live/Registered
COOK MEDICAL TECHNOLOGIES LLC
1991-12-23

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