Rutner J-RSB-142200

GUDID 00827002173194

Rutner Suprapubic Balloon Catheter Set

COOK INCORPORATED

Suprapubic drainage catheter
Primary Device ID00827002173194
NIH Device Record Key088d5fab-996f-4d91-a215-f46c5fb60a35
Commercial Distribution StatusIn Commercial Distribution
Brand NameRutner
Version Model NumberG17319
Catalog NumberJ-RSB-142200
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
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
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.
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.
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.
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.
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.
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.
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.
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
GS100827002173194 [Primary]

FDA Product Code

KOBCATHETER, SUPRAPUBIC (AND ACCESSORIES)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-24

On-Brand Devices [Rutner]

00827002152618Rutner Suprapubic Balloon Catheter Set
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00827002149205Rutner Suprapubic Balloon Catheter Set
00827002146815Rutner Balloon Dilation Helical Stone Extractor
00827002145474Rutner Balloon Dilation Helical Stone Extractor
00827002145405Rutner Balloon Dilation Helical Stone Extractor
00827002145399Rutner Balloon Dilation Helical Stone Extractor
00827002143142Rutner Balloon Dilation Helical Stone Extractor
00827002142633Rutner Balloon Dilation Helical Stone Extractor
10827002140575Rutner Universal Wedge Catheter
10827002140568Rutner Universal Wedge Catheter
00827002261242Rutner Balloon Dilation Helical Stone Extractor
00827002173200Rutner Suprapubic Balloon Catheter Set
00827002173194Rutner Suprapubic Balloon Catheter Set
00827002165670Rutner Suprapubic Balloon Catheter Set
00827002165663Rutner Suprapubic Balloon Catheter Set
00827002165656Rutner Suprapubic Balloon Catheter Set
00827002161986Rutner Suprapubic Balloon Catheter Set

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