AMPLATZ GOOSE NECK™

GUDID 00763000225292

SNARE GN2501 GOOSENECK SNARE V01

EV3, INC

Intravascular extraction catheter-snare
Primary Device ID00763000225292
NIH Device Record Keydfd88b1c-289d-4d67-ae9b-8949a8cefe98
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMPLATZ GOOSE NECK™
Version Model NumberGN2501
Company DUNS117446916
Company NameEV3, 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
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

Device Dimensions

Outer Diameter2 Millimeter
Catheter Inner Diameter1.6 Millimeter
Device Size Text, specify0
Catheter Working Length48 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2 Millimeter
Catheter Inner Diameter1.6 Millimeter
Device Size Text, specify0
Catheter Working Length48 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2 Millimeter
Catheter Inner Diameter1.6 Millimeter
Device Size Text, specify0
Catheter Working Length48 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2 Millimeter
Catheter Inner Diameter1.6 Millimeter
Device Size Text, specify0
Catheter Working Length48 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2 Millimeter
Catheter Inner Diameter1.6 Millimeter
Device Size Text, specify0
Catheter Working Length48 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2 Millimeter
Catheter Inner Diameter1.6 Millimeter
Device Size Text, specify0
Catheter Working Length48 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2 Millimeter
Catheter Inner Diameter1.6 Millimeter
Device Size Text, specify0
Catheter Working Length48 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2 Millimeter
Catheter Inner Diameter1.6 Millimeter
Device Size Text, specify0
Catheter Working Length48 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2 Millimeter
Catheter Inner Diameter1.6 Millimeter
Device Size Text, specify0
Catheter Working Length48 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2 Millimeter
Catheter Inner Diameter1.6 Millimeter
Device Size Text, specify0
Catheter Working Length48 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2 Millimeter
Catheter Inner Diameter1.6 Millimeter
Device Size Text, specify0
Catheter Working Length48 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2 Millimeter
Catheter Inner Diameter1.6 Millimeter
Device Size Text, specify0
Catheter Working Length48 Centimeter
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

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 *Store away from sunlight at room temperature in a dry place.
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 *Store away from sunlight at room temperature in a dry place.
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 *Store away from sunlight at room temperature in a dry place.
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 *Store away from sunlight at room temperature in a dry place.
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 *Store away from sunlight at room temperature in a dry place.
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 *Store away from sunlight at room temperature in a dry place.
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 *Store away from sunlight at room temperature in a dry place.
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 *Store away from sunlight at room temperature in a dry place.
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 *Store away from sunlight at room temperature in a dry place.
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 *Store away from sunlight at room temperature in a dry place.
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 *Store away from sunlight at room temperature in a dry place.
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 *Store away from sunlight at room temperature in a dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000225292 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXECatheter, embolectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-07-08
Device Publish Date2020-11-13

On-Brand Devices [AMPLATZ GOOSE NECK™]

00763000225421SNARE SK701 MICRO SNARE V01
00763000225414SNARE SK700 MICRO SNARE V01
00763000225407SNARE SK401 MICRO SNARE V01
00763000225391SNARE SK400 MICRO SNARE V01
00763000225384SNARE SK201 MICRO SNARE V01
00763000225377SNARE SK200 MICRO SNARE V01
00763000225360ACCESSORY MC6001 ANGIO CATHETERS V01
00763000225353ACCESSORY MC6000 ANGIO CATHETERS V01
00763000225346ACCESSORY MC4001 ANGIO CATHETERS V01
00763000225339ACCESSORY MC4000 ANGIO CATHETERS V01
00763000225322SNARE GN500 GOOSENECK SNARE V01
00763000225315SNARE GN3500 GOOSENECK SNARE V01
00763000225308SNARE GN3000 GOOSENECK SNARE V01
00763000225292SNARE GN2501 GOOSENECK SNARE V01
00763000225285SNARE GN2500 GOOSENECK SNARE V01
00763000225278SNARE GN2000 GOOSENECK SNARE V01
00763000225261SNARE GN1500 GOOSENECK SNARE V01
00763000225254SNARE GN1001 GOOSENECK SNARE V01
00763000225247SNARE GN1000 GOOSENECK SNARE V01
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.