Surity Female External Catheter 38011

GUDID 07333387055329

Non-invasive, single-use device for management of urinary incontinence in adults with female anatomy

Wellspect AB

Female wearable urinal, single-use
Primary Device ID07333387055329
NIH Device Record Key7e25f950-983f-4fad-8599-ffdb40b26866
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurity Female External Catheter
Version Model Number38011
Catalog Number38011
Company DUNS351118942
Company NameWellspect AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)456-3742
EmailUSinfo@wellspect.com
Phone+1(877)456-3742
EmailUSinfo@wellspect.com
Phone+1(877)456-3742
EmailUSinfo@wellspect.com
Phone+1(877)456-3742
EmailUSinfo@wellspect.com
Phone+1(877)456-3742
EmailUSinfo@wellspect.com
Phone+1(877)456-3742
EmailUSinfo@wellspect.com
Phone+1(877)456-3742
EmailUSinfo@wellspect.com
Phone+1(877)456-3742
EmailUSinfo@wellspect.com
Phone+1(877)456-3742
EmailUSinfo@wellspect.com
Phone+1(877)456-3742
EmailUSinfo@wellspect.com
Phone+1(877)456-3742
EmailUSinfo@wellspect.com
Phone+1(877)456-3742
EmailUSinfo@wellspect.com
Phone+1(877)456-3742
EmailUSinfo@wellspect.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107333387055312 [Package]
Contains: 07333387056630
Package: [3 Units]
In Commercial Distribution
GS107333387055329 [Package]
Contains: 07333387056630
Package: [30 Units]
In Commercial Distribution
GS107333387056630 [Primary]
GS107333387056821 [Package]
Contains: 07333387055312
Package: [16 Units]
In Commercial Distribution
GS107333387056838 [Package]
Package: [3 Units]
In Commercial Distribution

FDA Product Code

NZUCollector, urine, powered, non indwelling catheter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-29
Device Publish Date2025-12-19

Devices Manufactured by Wellspect AB

07333387055329 - Surity Female External Catheter2025-12-29Non-invasive, single-use device for management of urinary incontinence in adults with female anatomy
07333387055329 - Surity Female External Catheter2025-12-29 Non-invasive, single-use device for management of urinary incontinence in adults with female anatomy
07333387054537 - LoFric® Origo™2025-12-02 Single Use Urinary Catheter with salt solution. LoFric Origo Sleeve Coudé FX Male 40cm FR12, Sterile device.
07333387054575 - LoFric® Origo™2025-12-02 Single Use Urinary Catheter with salt solution. LoFric Origo Sleeve Coudé FX Male 40cm FR14, Sterile device.
07333387054605 - LoFric® Origo™2025-12-02 Single Use Urinary Catheter with salt solution. LoFric Origo Sleeve Coudé FX Male 40cm FR16, Sterile device.
07333387054353 - LoFric® Origo™2025-08-04 Single Use Urinary Catheter with salt solution. LoFric Origo Coudé FX Male 40cm CH12 / Coudé FX 16" 12FR, Sterile device.
07333387054377 - LoFric® Origo™2025-08-04 Single Use Urinary Catheter with salt solution. LoFric Origo Coudé FX Male 40cm CH14 / Coudé FX 16" 14FR, Sterile device.
07333387054421 - LoFric® Origo™2025-08-04 Single Use Urinary Catheter with salt solution. LoFric Origo Coudé FX Male 40cm CH16 / Coudé FX 16" 16FR, Sterile device.
07333387052564 - Navina™ Catheter Set Cone2025-01-20 Navina Transanal Irrigation. Rectal Catheter set cone. 10 Rectal catheters cone. Single use. Non sterile Device. Rx Only.

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