T-SPeC 114

GUDID 00856995003010

Transurethral Suprapubic endo-Cystostomy

SWAN VALLEY MEDICAL, INCORPORATED

Suprapubic drainage catheter
Primary Device ID00856995003010
NIH Device Record Key591d7a18-0c9c-4b89-8f53-8acc75579f89
Commercial Distribution StatusIn Commercial Distribution
Brand NameT-SPeC
Version Model NumberT14
Catalog Number114
Company DUNS795608012
Company NameSWAN VALLEY MEDICAL, INCORPORATED
Device Count1
DM Exemptfalse
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

Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com
Phone406-837-1500
Emailcs@swanvalleymedical.com

Device Dimensions

Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100856995003010 [Primary]
GS108569950031141 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KOBCatheter, Suprapubic (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-04-01
Device Publish Date2020-03-10

On-Brand Devices [T-SPeC]

00856995003010Transurethral Suprapubic endo-Cystostomy
00856995003003Transurethral Suprapubic endo-Cystostomy
08569950031141Transurethral Suprapubic endo-Cystostomy
08569950031073Transurethral Suprapubic endo-Cystostomy

Trademark Results [T-SPeC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
T-SPEC
T-SPEC
98222761 not registered Live/Pending
Swan Valley Medical, Inc.
2023-10-13
T-SPEC
T-SPEC
88861163 not registered Live/Pending
Nissan Jidosha Kabushiki Kaisha
2020-04-06
T-SPEC
T-SPEC
85672663 4292325 Live/Registered
Swan Valley Medical, Incorporated
2012-07-10
T-SPEC
T-SPEC
77433197 4171930 Live/Registered
Swan Valley Medical, Incorporated
2008-03-27

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