Ballast 088 Long Sheath N/A

GUDID 00840303712688

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	00840303712688
NIH Device Record Key	165796f3-67a4-49c8-a0d0-dd4c182b001f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Ballast 088 Long Sheath
Version Model Number	BALLAST90SD
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

Device Dimensions

Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
Device Size Text, specify	0
Catheter Inner Diameter	0.088 Inch
Catheter Working Length	90 Centimeter
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840303712688 [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	2024-08-22
Device Publish Date	2024-08-14

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