Atala-Steinbock 118014

GUDID 00827002152328

Atala-Steinbock Balloon Follower

COOK INCORPORATED

Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use
Primary Device ID00827002152328
NIH Device Record Keyf78db759-4895-4a1c-81de-479b8ce74f9d
Commercial Distribution Discontinuation2017-08-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAtala-Steinbock
Version Model NumberG15232
Catalog Number118014
Company DUNS042823948
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100827002152328 [Primary]

FDA Product Code

KOEDILATOR, URETHRAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-06-11
Device Publish Date2016-09-24

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00827002215009 - COOK2024-04-03 GLO-TIP ERCP CATHETER
00827002217652 - COOK2024-04-03 CLASSIC ERCP CATHETER
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