Axium Prime APB-4-10-3D-SS

GUDID 00836462013490

Detachable Coil System

Micro Therapeutics, Inc.

Non-neurovascular embolization coil
Primary Device ID00836462013490
NIH Device Record Keyf0bda3c0-1088-4057-88e4-b65995ca1857
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxium Prime
Version Model NumberAPB-4-10-3D-SS
Catalog NumberAPB-4-10-3D-SS
Company DUNS826110710
Company NameMicro Therapeutics, 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Outer Diameter4 Millimeter
Length10 Centimeter
Outer Diameter4 Millimeter
Length10 Centimeter
Outer Diameter4 Millimeter
Length10 Centimeter
Outer Diameter4 Millimeter
Length10 Centimeter
Outer Diameter4 Millimeter
Length10 Centimeter
Outer Diameter4 Millimeter
Length10 Centimeter
Outer Diameter4 Millimeter
Length10 Centimeter
Outer Diameter4 Millimeter
Length10 Centimeter
Outer Diameter4 Millimeter
Length10 Centimeter
Outer Diameter4 Millimeter
Length10 Centimeter
Outer Diameter4 Millimeter
Length10 Centimeter
Outer Diameter4 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing AgencyDevice ID
GS100836462013490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRDDevice, Vascular, for Promoting Embolization

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 Date2015-10-16

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