SYPHONTRAK GEN-10815-105

GUDID 00816900020310

Intermediate Catheter, Hemostasis Valve, & Introducer

Inneuroco, Inc.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID00816900020310
NIH Device Record Key6f5d51b6-5701-4a2e-be35-9d96f33b3db6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYPHONTRAK
Version Model NumberGEN-10815-105
Catalog NumberGEN-10815-105
Company DUNS080407341
Company NameInneuroco, Inc.
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com
Phone(954) 742-5988
EmailComplaints@InNeuroCo.com

Device Dimensions

Outer Diameter0.076 Inch
Outer Diameter0.076 Inch
Outer Diameter0.076 Inch
Outer Diameter0.076 Inch
Outer Diameter0.076 Inch
Outer Diameter0.076 Inch
Outer Diameter0.076 Inch
Outer Diameter0.076 Inch
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length105 Centimeter
Outer Diameter0.076 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100816900020310 [Primary]

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-23
Device Publish Date2017-11-08

On-Brand Devices [SYPHONTRAK]

00816900020334Intermediate Catheter, Hemostasis Valve, & Introducer
00816900020327Intermediate Catheter, Hemostasis Valve, & Introducer
00816900020310Intermediate Catheter, Hemostasis Valve, & Introducer

Trademark Results [SYPHONTRAK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYPHONTRAK
SYPHONTRAK
87245287 5366180 Live/Registered
Johnson & Johnson
2016-11-22
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