FDA.reportPublic FDA data

LUTONIX® Drug Coated Balloon

Primary DI
00801741105012
Brand
LUTONIX® Drug Coated Balloon
Company
LUTONIX, INC.
Model
BSCLX351305150
Catalog number
BSCLX351305150
Device description
"LUTONIX® 035 Drug Coated Balloon PTA Catheter .035"" 130cm 5x150mm"
Published
2015-07-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OURSacroiliac joint fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741105012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741105012008017411050128017411050120801741105012

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, drug-coatedA sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
946734808
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741187704LUTONIX® Drug Coated BalloonLX35757100VLX35757100V2020-01-31
00801741163432LUTONIX® Drug Coated BalloonLX351307805FLX351307805F2018-09-14
00801741177422LUTONIX® Drug Coated BalloonLX1810062205FLX1810062205F2019-01-11
00801741187698LUTONIX® Drug Coated BalloonLX3575780VLX3575780V2020-01-31
00801741184673LUTONIX® Drug Coated BalloonLX1810043005FLX1810043005F2020-01-28
00801741184697LUTONIX® Drug Coated BalloonLX1810063005FLX1810063005F2020-01-29
00801741123320LUTONIX® Drug Coated BalloonLX351307605FLX351307605F2016-04-25
00801741135330LUTONIX ® 035 Drug Coated Balloon PTA CatheterLX35754100VLX35754100V2017-08-28
00801741135378LUTONIX ® 035 Drug Coated Balloon PTA CatheterLX35755100VLX35755100V2017-08-28
00801741135385LUTONIX ® 035 Drug Coated Balloon PTA CatheterLX3575640VLX3575640V2017-08-28
00801741135392LUTONIX ® 035 Drug Coated Balloon PTA CatheterLX3575660VLX3575660V2017-08-28
00801741135415LUTONIX ® 035 Drug Coated Balloon PTA CatheterLX35756100VLX35756100V2017-08-28
00801741135439LUTONIX ® 035 Drug Coated Balloon PTA CatheterLX3575760VLX3575760V2017-08-28
00801741163456LUTONIX® Drug Coated BalloonLX3513071205FLX3513071205F2018-09-14
00801741163470LUTONIX® Drug Coated BalloonLX3513072205FLX3513072205F2018-09-14
00801741177279LUTONIX® Drug Coated BalloonLX1810041504FLX1810041504F2019-01-10
00801741177286LUTONIX® Drug Coated BalloonLX1810042204FLX1810042204F2019-01-11
00801741177316LUTONIX® Drug Coated BalloonLX181005805FLX181005805F2019-01-29
00801741177323LUTONIX® Drug Coated BalloonLX1810051005FLX1810051005F2019-01-29
00801741177330LUTONIX® Drug Coated BalloonLX1810051205FLX1810051205F2019-01-29

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