FDA.reportPublic FDA data

SimPro™ Set

Primary DI
07333387043661
Brand
SimPro™ Set
Company
Wellspect AB
Model
5300800
Catalog number
5300800
Device description
Single Use Urinary Catheter with water sachet and Accessories. Male Nelaton 16" 08FR
Published
2024-05-01
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
EYYDrape, urological, disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYYDrape, Urological, DisposableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333387043654PackageGS110In Commercial Distribution
07333387043661PackageGS14In Commercial Distribution
07392532189241PreviousGS10
07333387043647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333387043654073333870436547333387043654
07333387043661073333870436617333387043661
07392532189241073925321892417392532189241
07333387043647073333870436477333387043647

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, Specify00Store in a dry place at room temperature.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)456-3742AnkaraTUR-Info@wellspect.com

Regulatory Flags#

DUNS number
351118942
Device count
1
DM exempt
false
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
07333387055695LoFric Elle Pro41910502026-05-20
07333387055725LoFric Elle Pro41912502026-05-20
07333387055756LoFric Elle Pro41914502026-05-20
07333387056623Surity Male External Catheter3802138021402026-04-27
07333387056630Surity Female External Catheter3801138011402025-12-19
07333387055329Surity Female External Catheter38011380112025-12-19
07333387053110LoFric® Origo™4491244912402025-11-24
07333387053127LoFric® Origo™4491444914402025-11-24
07333387053134LoFric® Origo™4491644916402025-11-24
07333387054537LoFric® Origo™4491244912402025-11-24
07333387054575LoFric® Origo™4491444914402025-11-24
07333387054605LoFric® Origo™4491644916402025-11-24
07333387052953LoFric® Origo™4471244712402025-07-25
07333387053059LoFric® Origo™4471444714402025-07-25
07333387053066LoFric® Origo™4471644716402025-07-25
07333387054353LoFric® Origo™4471244712402025-07-25
07333387054377LoFric® Origo™4471444714402025-07-25
07333387054421LoFric® Origo™4471644716402025-07-25
07333387002200LoFric® Origo™4451244512402024-08-25
07333387002217LoFric® Origo™4451444514402024-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426262076AQUABLATION THERAPY®Microtek Medical LLCEYY2026-04-06
00850055427099Essential Drape 1PKPROCEPT BioRobotics CorporationEYY2025-03-13
10850055427096Essential Drape 1PKPROCEPT BIOROBOTICS CORPORATIONEYY2025-03-13
07333387043913GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387043944GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387043975GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044002GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044033GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044064GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044095GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044125GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044156GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044187GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044217GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044248GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044279GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044309GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044330GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044361GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387043951GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETIEYY2024-06-01
07333387044040GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETIEYY2024-06-01
07333387044200GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETIEYY2024-06-01
07333387044347GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETIEYY2024-06-01
07333387043678SimPro™ SetWellspect ABEYY2024-05-02
07333387043739SimPro™ SetWellspect ABEYY2024-05-02
07333387043852SimPro™ SetWellspect ABEYY2024-05-02
07333387043494SimPro™ SetWellspect ABEYY2024-05-01
07333387043555SimPro™ SetWellspect ABEYY2024-05-01
07333387043616SimPro™ SetWellspect ABEYY2024-05-01
07333387043647SimPro™ SetWellspect ABEYY2024-05-01