Amsel Occluder Device 100-200

GUDID 00857774006000

The Amsel Occluder Device is designed to easily and securely close blood vessels (veins or arteries as well as hollow ducts) during surgical procedures. It is intended for use in open general surgery procedures on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.

AMSEL MEDICAL CORPORATION

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• Primary Device ID: 00857774006000
• NIH Device Record Key: 417e7f0c-8fb7-46a6-851a-9f010ab26196
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amsel Occluder Device
• Version Model Number: 100-200
• Catalog Number: 100-200
• Company DUNS: 078410514
• Company Name: AMSEL MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (617)3958825
• Email: raanan@amseltech.com
• Phone: (617)3958825
• Email: raanan@amseltech.com
• Phone: (617)3958825
• Email: raanan@amseltech.com
• Phone: (617)3958825
• Email: raanan@amseltech.com
• Phone: (617)3958825
• Email: raanan@amseltech.com
• Phone: (617)3958825
• Email: raanan@amseltech.com
• Phone: (617)3958825
• Email: raanan@amseltech.com
• Phone: (617)3958825
• Email: raanan@amseltech.com
• Phone: (617)3958825
• Email: raanan@amseltech.com
• Phone: (617)3958825
• Email: raanan@amseltech.com
• Phone: (617)3958825
• Email: raanan@amseltech.com
• Phone: (617)3958825
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com
• Phone: (857)777-0040
• Email: raanan@amseltech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857774006000 [Primary]
GS1	10857774006007 [Package]; Package: Single Box [1 Units]; In Commercial Distribution
GS1	20857774006004 [Package]; Contains: 10857774006007; Package: Box of 6 [6 Units]; In Commercial Distribution
GS1	30857774006001 [Package]; Contains: 20857774006004; Package: Master Box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140932

FDA Product Code

• FZP: Clip, Implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-26