Abre™

GUDID 00643169796294

STENT AB9U14080090 ABRE V01

MEDTRONIC, INC.

Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent
Primary Device ID00643169796294
NIH Device Record Key73e2d7ae-a217-4b59-90cb-6fb3c5d8f7cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbre™
Version Model NumberAB9U14080090
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Stent Length80 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Stent Length80 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Stent Length80 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Stent Length80 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Stent Length80 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Stent Length80 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Stent Length80 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Stent Length80 Millimeter
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169796294 [Primary]
GS100643169796294 [Primary]
GS100643169796294 [Primary]
GS100643169796294 [Primary]
GS100643169796294 [Primary]
GS100643169796294 [Primary]
GS100643169796294 [Primary]
GS100643169796294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QANStent, iliac vein
QANStent, iliac vein
QANStent, iliac vein
QANStent, iliac vein
QANStent, iliac vein
QANStent, iliac vein
QANStent, iliac vein
QANStent, iliac vein

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-11-01

On-Brand Devices [Abre™]

00643169796478STENT AB9U20150090 ABRE V01
00643169796461STENT AB9U20120090 ABRE V01
00643169796454STENT AB9U20100090 ABRE V01
00643169796447STENT AB9U20080090 ABRE V01
00643169796430STENT AB9U20060090 ABRE V01
00643169796423STENT AB9U18150090 ABRE V01
00643169796416STENT AB9U18120090 ABRE V01
00643169796409STENT AB9U18100090 ABRE V01
00643169796393STENT AB9U18080090 ABRE V01
00643169796386STENT AB9U18060090 ABRE V01
00643169796379STENT AB9U16150090 ABRE V01
00643169796362STENT AB9U16120090 ABRE V01
00643169796355STENT AB9U16100090 ABRE V01
00643169796348STENT AB9U16080090 ABRE V01
00643169796331STENT AB9U16060090 ABRE V01
00643169796324STENT AB9U14150090 ABRE V01
00643169796317STENT AB9U14120090 ABRE V01
00643169796300STENT AB9U14100090 ABRE V01
00643169796294STENT AB9U14080090 ABRE V01
00643169796287STENT AB9U14060090 ABRE V01
00643169796263STENT AB9U12150090 ABRE V01
00643169796256STENT AB9U12120090 ABRE V01
00643169796249STENT AB9U12100090 ABRE V01
00643169796232STENT AB9U12080090 ABRE V01
00643169796225STENT AB9U12060090 ABRE V01
00643169796201STENT AB9U10150090 ABRE V01
00643169796195STENT AB9U10120090 ABRE V01
00643169796188STENT AB9U10100090 ABRE V01
00643169796171STENT AB9U10080090 ABRE V01
00643169796164STENT AB9U10060090 ABRE V01
00643169796157STENT AB9U10040090 ABRE V01

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