Intermediate Catheter GEN-10815-115

GUDID 00816900020013

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 ID00816900020013
NIH Device Record Key93ed0ab8-ef00-4ba5-8176-e184f28ccf1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntermediate Catheter
Version Model NumberGEN-10815-115
Catalog NumberGEN-10815-115
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
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 Centimeter
Outer Diameter0.076 Inch
Lumen/Inner Diameter0.06 Inch
Length115 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
GS100816900020013 [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 [Intermediate Catheter]

00816900020037Intermediate Catheter, Hemostasis Valve, & Introducer
00816900020020Intermediate Catheter, Hemostasis Valve, & Introducer
00816900020013Intermediate Catheter, Hemostasis Valve, & Introducer
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