ECLIPSE 2L N/A

GUDID 00818053022920

ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. The guidewire lumen or the working lumen is DMSO compatible and can be used for infusion/delivery of diagnostic and therapeutic devices. The inflation lumen is used for the inflation and deflation of the balloon. The inflation and deflation of the balloon can be achieved independently of the presence of the guidewire. ECLIPSE 2L balloon catheter is equipped with a non-detachable low inflation pressure super compliant balloon welded to the distal end of the catheter.

BALT USA LLC

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Primary Device ID00818053022920
NIH Device Record Keyb42898b2-bef2-4f38-82a5-768c55f465a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameECLIPSE 2L
Version Model NumberECL2L6x7
Catalog NumberN/A
Company DUNS945543689
Company NameBALT USA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com

Device Dimensions

Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch
Length160 Centimeter
Catheter Inner Diameter0.016 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light

Device Identifiers

Device Issuing AgencyDevice ID
GS100818053022920 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-23
Device Publish Date2019-07-15

On-Brand Devices [ECLIPSE 2L ]

00818053023002ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. T
00818053022982ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. T
00818053022968ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. T
00818053022944ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. T
00818053022937ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. T
00818053022920ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. T

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