Super Distal Access (SDA) GEN-10820-135

GUDID 00816900020099

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 ID00816900020099
NIH Device Record Keyadb71f17-bb64-4f77-9a83-d77aa9dc1214
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuper Distal Access (SDA)
Version Model NumberGEN-10820-135
Catalog NumberGEN-10820-135
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.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn
Phone(954) 742-5988
EmailComplaints@InNeuroCo.comn

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
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 Inch
Lumen/Inner Diameter0.062 Inch
Length135 Centimeter
Outer Diameter0.083 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
GS100816900020099 [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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