FDA.reportPublic FDA data

GentleCathTM

Primary DI
00768455136292
Brand
GentleCathTM
Company
OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI
Model
509013
Catalog number
509013
Device description
Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 16FR
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZDCATHETER, STRAIGHT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00768455136292PackageGS110In Commercial Distribution
10768455136299PackageGS14In Commercial Distribution
00768455142811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455136292007684551362927684551362920768455136292
1076845513629910768455136299
00768455142811007684551428117684551428110768455142811

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French
Length16Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)422-8818cic@convatec.com

Regulatory Flags#

DUNS number
534998190
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00768455142576GentleCathTM5089895089892016-09-23
00768455142583GentleCathTM5089905089902016-09-23
00768455142590GentleCathTM5089915089912016-09-23
00768455142606GentleCathTM5089925089922016-09-23
00768455142637GentleCathTM5089955089952016-09-23
00768455142644GentleCathTM5089965089962016-09-23
00768455142651GentleCathTM5089975089972016-09-23
00768455142668GentleCathTM5089985089982016-09-23
00768455142675GentleCathTM5089995089992016-09-23
00768455142682GentleCathTM5090005090002016-09-23
00768455142699GentleCathTM5090015090012016-09-23
00768455142705GentleCathTM5090025090022016-09-23
00768455142712GentleCathTM5090035090032016-09-23
00768455142729GentleCathTM5090045090042016-09-23
00768455142736GentleCathTM5090055090052016-09-23
00768455142743GentleCathTM5090065090062016-09-23
00768455142750GentleCathTM5090075090072016-09-23
00768455142767GentleCathTM5090085090082016-09-23
00768455142774GentleCathTM5090095090092016-09-23
00768455142781GentleCathTM5090105090102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344162031MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-20
10197344162178MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-14
10197344162024MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162048MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162055MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162062MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162079MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162116MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162123MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162130MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162147MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162154MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162161MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162185MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162192MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162208MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162215MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162222MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162239MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162246MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162253MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162260MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162277MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162284MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10704411008828AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008835AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008842AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008859AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008873AMSure®HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008880AMSure®HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02