AMPLATZ GOOSE NECK GN1001

GUDID 00821684004067

Snare Kit

Covidien LP

Intravascular catheter-snare

• Primary Device ID: 00821684004067
• NIH Device Record Key: cae69df4-5ea2-4421-b8f5-86f7e8ce78ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMPLATZ GOOSE NECK
• Version Model Number: GN1001
• Catalog Number: GN1001
• Company DUNS: 968903703
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Outer Diameter: 0.038 Inch
• Length: 65 Centimeter
• Outer Diameter: 10 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684004067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972511

FDA Product Code

• DXE: CATHETER, EMBOLECTOMY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-10
• Device Publish Date: 2015-10-16

On-Brand Devices [AMPLATZ GOOSE NECK]

• 00821684005064: Microsnare Kit
• 00821684005057: Microsnare Kit
• 00821684005040: Microsnare Kit
• 00821684005033: Microsnare Kit
• 00821684005026: Microsnare Kit
• 00821684005019: Microsnare Kit
• 00821684004180: Snare Catheter
• 00821684004173: Snare Catheter
• 00821684004166: Snare Catheter
• 00821684004159: Snare Catheter
• 00821684004128: Snare Kit
• 00821684004111: Snare Kit
• 00821684004074: Snare Kit
• 00821684004067: Snare Kit
• 00821684004050: Snare Kit
• 00821684004043: Snare Kit
• 00821684004036: Snare Kit
• 00821684004029: Snare Kit
• 00821684004012: Snare Kit