ProVia 12

GUDID 20643169452750

GDWR 12PROV180SS ProVia 5pk 180 Si ST

MEDTRONIC, INC.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID20643169452750
NIH Device Record Key81e40b4f-c9a5-489a-b44c-45eaf7cb5312
Commercial Distribution StatusIn Commercial Distribution
Brand NameProVia 12
Version Model Number12PROV180SS
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
GS100643169452756 [Primary]
GS120643169452750 [Package]
Contains: 00643169452756
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 12]

20643169452767GDWR 12PROV180HS ProVia 5pk 180 HY ST
20643169452750GDWR 12PROV180SS ProVia 5pk 180 Si ST
00643169452749GDWR 12PROV300HS ProVia 5pk 300 HY ST
20643169452736GDWR 12PROV300SS ProVia 5pk 300 Si ST
20763000569796GDWR 12PROV180HS PROVIA 5PK 180 HY ST
20763000569789GDWR 12PROV180SS PROVIA 5PK 180 SI ST
20763000569772GDWR 12PROV300HS PROVIA 5PK 300 HY ST
20763000569765GDWR 12PROV300SS PROVIA 5PK 300 SI ST

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