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 ID	00818053022883
NIH Device Record Key	0c94f9b4-d40c-4bfa-b3f2-bb7dda167d5e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Ballast 088 Long Sheath
Version Model Number	BALLAST80
Catalog Number	N/A
Company DUNS	945543689
Company Name	BALT USA LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com
Phone	1-949-788-1443
Email	customerservice@balt-usa.com

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818053022883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182918

FDA Product Code

DQY	Catheter, Percutaneous

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-07-23
Device Publish Date	2019-07-15

On-Brand Devices [Ballast 088 Long Sheath]

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