GentleCathTM 509012

GUDID 07333387044170

Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 14FR

OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI

Single-administration urethral catheterization kit, single-use
Primary Device ID07333387044170
NIH Device Record Key25b5a876-9dd7-4e3b-8fb9-33f85894e86f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleCathTM
Version Model Number509012
Catalog Number509012
Company DUNS534998190
Company NameOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com
Phone+1(800)422-8818
Emailcic@convatec.com

Device Dimensions

Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100768455142804 [Previous]
GS107333387044156 [Primary]
GS107333387044163 [Package]
Contains: 07333387044156
Package: [10 Units]
In Commercial Distribution
GS107333387044170 [Package]
Contains: 07333387044163
Package: [4 Units]
In Commercial Distribution

FDA Product Code

NWOKit, catheter, urinary (exludes HIV testing)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-10
Device Publish Date2024-06-01

On-Brand Devices [GentleCathTM]

10768455136350Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 18FR
00768455136346Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 16FR
10768455136336Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 14FR
00768455136322Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 12FR
00768455136315Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 10FR
10768455136305Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 18FR
00768455136292Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 16FR
00768455136285Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 14FR
00768455136278Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 12FR
10768455136268Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 10FR
10768455136251Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 08FR
10768455136244Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 16FR
10768455136237Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 14FR
00768455136223Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 12FR
10768455136213Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 10FR
00768455136209Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 08FR
00768455136193Hydrophilic Intermittent Urinary Catheter With Water Sachet Tiemann 16'' 18FR
10768455136183Hydrophilic Intermittent Urinary Catheter With Water Sachet Tiemann 16'' 16FR
10768455136176Hydrophilic Intermittent Urinary Catheter With Water Sachet Tiemann 16'' 14FR
10768455136169Hydrophilic Intermittent Urinary Catheter With Water Sachet Tiemann 16'' 12FR
00768455136155Hydrophilic Intermittent Urinary Catheter With Water Sachet Tiemann 16'' 10FR
10768455136145Hydrophilic Intermittent Urinary Catheter With Water Sachet Male 16'' 18FR
00768455136131Hydrophilic Intermittent Urinary Catheter With Water Sachet Male 16'' 16FR
10768455136121Hydrophilic Intermittent Urinary Catheter With Water Sachet Male 16'' 14FR
00768455136117Hydrophilic Intermittent Urinary Catheter With Water Sachet Male 16'' 12FR
00768455136100Hydrophilic Intermittent Urinary Catheter With Water Sachet Male 16'' 10FR
10768455136091Hydrophilic Intermittent Urinary Catheter With Water Sachet Male 16'' 08FR
00768455136087Hydrophilic Intermittent Urinary Catheter With Water Sachet Female 8'' 16FR
10768455136077Hydrophilic Intermittent Urinary Catheter With Water Sachet Female 8'' 14FR
10768455136060Hydrophilic Intermittent Urinary Catheter With Water Sachet Female 8'' 12FR
10768455136053Hydrophilic Intermittent Urinary Catheter With Water Sachet Female 8'' 10FR
00768455136049Hydrophilic Intermittent Urinary Catheter With Water Sachet Female 8'' 08FR
07333387044385Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 18FR
07333387044347Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 16FR
07333387044316Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 14FR
07333387044293Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 12FR
07333387044255Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 10FR
07333387044231Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 18FR
07333387044200Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 16FR
07333387044170Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 14FR
07333387044149Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 12FR
07333387044101Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 10FR
07333387044088Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 08FR
07333387044040Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 16FR
07333387044019Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 14FR
07333387043999Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 12FR
07333387043951Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 10FR
07333387043920Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 08FR
07333387031958Hydrophilic Intermittent Urinary Catheter With Water Sachet Tiemann 16'' 18FR
07333387031927Hydrophilic Intermittent Urinary Catheter With Water Sachet Tiemann 16'' 16FR

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.