Chocolate®

GUDID 00763000336622

PTA CB1413535040 CHOCOLATE 014 V03

EV3, INC

Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic
Primary Device ID00763000336622
NIH Device Record Keya0bda301-d4f3-407f-8ec5-3c2741ca8c24
Commercial Distribution StatusIn Commercial Distribution
Brand NameChocolate®
Version Model NumberCB1413535040OTW
Company DUNS117446916
Company NameEV3, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter
Balloon Length40 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000336622 [Primary]
GS100763000336622 [Primary]
GS100763000336622 [Primary]
GS100763000336622 [Primary]
GS100763000336622 [Primary]
GS100763000336622 [Primary]
GS100763000336622 [Primary]
GS100763000336622 [Primary]
GS100763000336622 [Primary]
GS100763000336622 [Primary]
GS100763000336622 [Primary]
GS100763000336622 [Primary]
GS100763000336622 [Primary]
GS100763000336622 [Primary]
GS100763000336622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [Chocolate®]

00763000336790PTA CB1812060120 CHOCOLATE 018 V03
00763000336783PTA CB1812060080 CHOCOLATE 018 V03
00763000336776PTA CB1812060040 CHOCOLATE 018 V03
00763000336769PTA CB1812050120 CHOCOLATE 018 V03
00763000336752PTA CB1812050080 CHOCOLATE 018 V03
00763000336745PTA CB1812050040 CHOCOLATE 018 V03
00763000336738PTA CB1415030120 CHOCOLATE 014 V03
00763000336721PTA CB1415030080 CHOCOLATE 014 V03
00763000336714PTA CB1415030040 CHOCOLATE 014 V03
00763000336707PTA CB1415025120 CHOCOLATE 014 V03
00763000336691PTA CB1415025080 CHOCOLATE 014 V03
00763000336684PTA CB1415025040 CHOCOLATE 014 V03
00763000336677PTA CB1413540120 CHOCOLATE 014 V03
00763000336660PTA CB1413540080 CHOCOLATE 014 V03
00763000336653PTA CB1413540040 CHOCOLATE 014 V03
00763000336646PTA CB1413535120 CHOCOLATE 014 V03
00763000336639PTA CB1413535080 CHOCOLATE 014 V03
00763000336622PTA CB1413535040 CHOCOLATE 014 V03

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