Super Distal Access (SDA) GEN-10820-115

GUDID 00816900020075

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 ID00816900020075
NIH Device Record Key06d2479c-9b18-4ca4-bb54-49bf91a57141
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuper Distal Access (SDA)
Version Model NumberGEN-10820-115
Catalog NumberGEN-10820-115
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 Diameter0.083 Inch
Outer Diameter0.083 Inch
Outer Diameter0.083 Inch
Outer Diameter0.083 Inch
Outer Diameter0.083 Inch
Outer Diameter0.083 Inch
Outer Diameter0.083 Inch
Outer Diameter0.083 Inch
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length115 Centimeter
Outer Diameter0.083 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in cool, dark, dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100816900020075 [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 [Super Distal Access (SDA)]

00816900020099Catheter, Hemostasis Valve, & Introducer
00816900020082Catheter, Hemostasis Valve, & Introducer
00816900020075Catheter, Hemostasis Valve, & Introducer
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