ProVia 3

GUDID 20643169453139

GDWR 3PROV180HS ProVia 5pk 180 HY ST

MEDTRONIC, INC.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID20643169453139
NIH Device Record Keyb045eb32-0d40-4d13-8785-260e8fe4ca67
Commercial Distribution StatusIn Commercial Distribution
Brand NameProVia 3
Version Model Number3PROV180HS
Company DUNS006261481
Company NameMEDTRONIC, 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

Device Dimensions

Outer Diameter0.014 Inch
Outer Diameter0.014 Inch
Outer Diameter0.014 Inch
Outer Diameter0.014 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place. Do not expose to organic solvents.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place. Do not expose to organic solvents.

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169453135 [Primary]
GS120643169453139 [Package]
Contains: 00643169453135
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWIRE, GUIDE, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-28

On-Brand Devices [ProVia 3]

20643169453139GDWR 3PROV180HS ProVia 5pk 180 HY ST
00643169453128GDWR 3PROV180SS ProVia 5pk 180 Si ST
20643169453115GDWR 3PROV300HS ProVia 5pk 300 HY ST
00643169453104GDWR 3PROV300SS ProVia 5pk 300 Si ST
20763000569918GDWR 3PROV180HS PROVIA 5PK 180 HY ST
20763000569901GDWR 3PROV180SS PROVIA 5PK 180 SI ST
20763000569895GDWR 3PROV300HS PROVIA 5PK 300 HY ST
20763000569888GDWR 3PROV300SS PROVIA 5PK 300 SI ST

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