Ballast 088 Long Sheath N/A

GUDID 00818053022883

The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide catheter/long sheath that is designed for facilitating the introduction of appropriately sized interventional devices into target blood vessels in the peripheral, coronary, and neuro vasculature.

BALT USA LLC

Vascular guide-catheter, single-use
Primary Device ID00818053022883
NIH Device Record Key0c94f9b4-d40c-4bfa-b3f2-bb7dda167d5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBallast 088 Long Sheath
Version Model NumberBALLAST80
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
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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
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
GS100818053022883 [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 [Ballast 088 Long Sheath]

00818053022913The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
00818053022906The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
00818053022890The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
00818053022883The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
00840303712817The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
00840303712800The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
00840303712794The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
00840303712787The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
00840303712688The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
00840303712671The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
00840303709497The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
00840303709480The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
00840303709473The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
00840303709466The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.