Chocolate®

Primary DI
00763000336745
Brand
Chocolate®
Company
EV3, INC
Model
CB1812050040OTW
Device description
PTA CB1812050040 CHOCOLATE 018 V03
Published
2020-06-15
Public version status
New
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
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130414000CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018Trireme Medical, Inc.2013-06-15LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000336745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000336745007630003367457630003367450763000336745

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, 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; 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. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter5Millimeter
Balloon Length40Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length120Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
117446916
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169996090TrailBlazer™SC-014-1352017-10-15
00643169996106TrailBlazer™SC-014-1502017-10-15
00643169996113TrailBlazer™SC-018-0902017-10-15
00643169996120TrailBlazer™SC-018-1352017-10-15
00643169996137TrailBlazer™SC-018-1502017-10-15
00643169996144TrailBlazer™SC-035-0652017-10-15
00643169996151TrailBlazer™SC-035-0902017-10-15
00643169996168TrailBlazer™SC-035-1352017-10-15
00643169996175TrailBlazer™SC-035-1502017-10-19
00763000104740TrailBlazer™SC-014-1352019-02-28
00763000104757TrailBlazer™SC-014-1502019-02-28
00763000104764TrailBlazer™SC-018-0902019-02-28
00763000104771TrailBlazer™SC-018-1352019-02-28
00763000104788TrailBlazer™SC-018-1502019-02-28
00763000104795TrailBlazer™SC-035-0652019-02-28
00763000104801TrailBlazer™SC-035-0902019-02-28
00763000104818TrailBlazer™SC-035-1352019-02-28
00763000104825TrailBlazer™SC-035-1502019-02-28
00821684057971TrailBlazer™SC-014-1352016-04-04
00821684057988TrailBlazer™SC-014-1502016-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033477048772REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048802REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048833REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048864REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048888REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048925REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048956REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048987REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049014REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049045REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049069REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049076REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049106REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049137REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049168REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049199REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049212REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049229REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049250REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049281REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049311REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049373REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049434REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049397REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049090REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048727REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048734REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048765REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048796REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048819REEF HPMEDTRONIC, INC.LIT2016-06-19