SUTURE LOOP HI-FI HL201

GUDID 20653405002083

SutureLoop Hi-Fi Suture 20 inch Loop (5 Metric) White/Blue, Hi-Fi Polyblend Suture, Curved Needle

Conmed Corporation

Suturing unit, single-use

• Primary Device ID: 20653405002083
• NIH Device Record Key: df7406ee-d97b-4095-ac0e-ca183d287c32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUTURE LOOP HI-FI
• Version Model Number: HL201
• Catalog Number: HL201
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 12
• 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(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405002089 [Unit of Use]
GS1	10653405002086 [Primary]
GS1	20653405002083 [Package]; Contains: 10653405002086; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100006

FDA Product Code

• GAT: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-06
• Device Publish Date: 2015-10-24

On-Brand Devices [SUTURE LOOP HI-FI]

• 20653405002083: SutureLoop Hi-Fi Suture 20 inch Loop (5 Metric) White/Blue, Hi-Fi Polyblend Suture, Curved Needl
• 20653405002052: SutureLoop Hi-Fi Suture, 20 inch Loop no. 2 (5 metric) White/Blue, Hi-FI Polyblend Suture, Strai