ReverseTM

GUDID 00847536021945

MICROCATHETER MIC-021-150 REVERSE

Reverse Medical Corporation

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID00847536021945
NIH Device Record Keye11a4735-9583-4a02-a55e-e0f59bbdcd58
Commercial Distribution StatusIn Commercial Distribution
Brand NameReverseTM
Version Model NumberMIC-021-150
Company DUNS963324913
Company NameReverse Medical Corporation
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
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100847536021945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

[00847536021945]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-01-23
Device Publish Date2016-09-25

On-Brand Devices [ReverseTM]

00847536021945MICROCATHETER MIC-021-150 REVERSE
00847536003569MIC-027-150 REVERSE MICROCATHETER
00847536003552MIC-021-150 REVERSE MICROCATHETER
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