FDA.reportPublic FDA data

GentleCathTM

Primary DI
07333387044088
Brand
GentleCathTM
Company
OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI
Model
509009
Catalog number
509009
Device description
Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 08FR
Published
2024-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAQBag, Urine Collection, Leg, For External Use, SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333387044071PackageGS110In Commercial Distribution
07333387044088PackageGS14In Commercial Distribution
00768455142774PreviousGS10
07333387044064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
07333387044071073333870440717333387044071
07333387044088073333870440887333387044088
00768455142774007684551427747684551427740768455142774
07333387044064073333870440647333387044064

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 Gauge8French
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
04046961018612ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCFAQ2026-03-16
04046961018650ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCFAQ2026-03-16
00850063139496Neil Medical Group Neil Medical GroupFAQ2025-12-08
00850063139502Neil Medical Group Neil Medical GroupFAQ2025-12-08
00850063139519Neil Medical Group Neil Medical GroupFAQ2025-12-08
00850063139526Neil Medical Group Neil Medical GroupFAQ2025-12-08
06975424198265Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198289Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198302Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198326Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198340Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198364Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198388Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198269Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198283Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198306Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198320Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198344Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198368Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198382Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06974500612558Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
06974500612565Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
06974500612572Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
16974500612555Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
16974500612562Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
16974500612579Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
00661392002241LSL HEALTHCARELSL Industries, LLCFAQ2025-05-16
10661392002248LSL HEALTHCARELSL Industries, LLCFAQ2025-05-16
00810113579764ViveVIVE HEALTH LLCFAQ2025-04-07
00810113579979ViveVIVE HEALTH LLCFAQ2025-04-07