Ikon 14 Pro Guidewire ICGW014300P

GUDID 00812212030825

Imperative Care Neurovascular Guidewire-Support, 0.014", 300cm

IMPERATIVE CARE, INC.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID00812212030825
NIH Device Record Key54a92511-d6a6-49c9-9b27-b4ea5964c777
Commercial Distribution StatusIn Commercial Distribution
Brand NameIkon 14 Pro Guidewire
Version Model NumberICGW014300P
Catalog NumberICGW014300P
Company DUNS080816678
Company NameIMPERATIVE CARE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com

Device Dimensions

Outer Diameter0.014 Inch
Guidewire Length300 Centimeter
Outer Diameter0.014 Inch
Guidewire Length300 Centimeter
Outer Diameter0.014 Inch
Guidewire Length300 Centimeter
Outer Diameter0.014 Inch
Guidewire Length300 Centimeter
Outer Diameter0.014 Inch
Guidewire Length300 Centimeter
Outer Diameter0.014 Inch
Guidewire Length300 Centimeter
Outer Diameter0.014 Inch
Guidewire Length300 Centimeter
Outer Diameter0.014 Inch
Guidewire Length300 Centimeter
Outer Diameter0.014 Inch
Guidewire Length300 Centimeter
Outer Diameter0.014 Inch
Guidewire Length300 Centimeter
Outer Diameter0.014 Inch
Guidewire Length300 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.

Device Identifiers

Device Issuing AgencyDevice ID
GS100812212030825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOFGuide, Wire, Catheter, Neurovasculature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-02
Device Publish Date2025-11-24

On-Brand Devices [Ikon 14 Pro Guidewire]

00812212030825Imperative Care Neurovascular Guidewire-Support, 0.014", 300cm
00812212030818Imperative Care Neurovascular Guidewire-Support, 0.014", 200cm

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