FDA.reportPublic FDA data

CROSSER®

Primary DI
10801741125611
Brand
CROSSER®
Company
Bard Peripheral Vascular, Inc.
Model
CRUOS106
Catalog number
CRUOS106
Device description
CROSSER® CTO Recanalization Catheter 14S, Over the Wire, 106cm
Published
2016-09-13
Public version status
Update
Distribution status
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
PDUCatheter for crossing total occlusions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDUCatheter For Crossing Total OcclusionsCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741125611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080174112561110801741125611

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical atherectomy system catheter, coronary/peripheralA sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of both coronary and peripheral arteries (or vein grafts). It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length106Centimeter

Contacts#

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

Regulatory Flags#

DUNS number
135057938
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

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00801741000331UltraClip® II Breast Tissue Marker8610178610172015-09-25
00801741032004SenoMark® Ultra Breast Tissue MarkerSMEC7CSMEC7C2015-10-02
00801741032011SenoMark® Ultra Breast Tissue MarkerSMEC7RSMEC7R2015-10-02
00801741032028SenoMark® Ultra Breast Tissue MarkerSMEC10CSMEC10C2015-10-01
00801741032035SenoMark® Ultra Breast Tissue MarkerSMEC10RSMEC10R2015-10-01
00801741032042SenoMark® Ultra Breast Tissue MarkerSMEC12CSMEC12C2015-10-01
00801741032059SenoMark® Ultra Breast Tissue MarkerSMEC12RSMEC12R2015-10-02
00801741032066SenoMark® Ultra Breast Tissue MarkerSMMA11CSMMA11C2015-10-01
00801741032073SenoMark® Ultra Breast Tissue MarkerSMMA11RSMMA11R2015-10-01
00801741032080SenoMark® Ultra Breast Tissue MarkerSMAT9CSMAT9C2015-10-02
00801741032097SenoMark® Ultra Breast Tissue MarkerSMAT9RSMAT9R2015-10-02
00801741032103SenoMark® Ultra Breast Tissue MarkerSMAT12CSMAT12C2015-10-01
00801741032110SenoMark® Ultra Breast Tissue MarkerSMAT12RSMAT12R2015-10-01
00801741032127SenoMark® Ultra Breast Tissue MarkerSMEV9CSMEV9C2015-10-02
00801741032134SenoMark® Ultra Breast Tissue MarkerSMEV9RSMEV9R2015-10-02
00801741032219UltraClip® Dual Trigger Breast Tissue Marker862017D862017D2015-09-25
00801741032226UltraClip® Dual Trigger Breast Tissue Marker862017DL862017DL2015-09-25
00801741032233UltraClip® Dual Trigger Breast Tissue Marker863017D863017D2015-09-25
00801741032240UltraClip® Dual Trigger Breast Tissue Marker863017DL863017DL2015-09-25
00801741032257UltraClip® Dual Trigger Breast Tissue Marker864017D864017D2015-09-25

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