ETHIBOND X805H

GUDID 30705031057962

Green Braided Nonabsorble Suture, Coated with Polybutilate

ETHICON, LLC

Polyester suture, non-bioabsorbable, multifilament

• Primary Device ID: 30705031057962
• NIH Device Record Key: 7911dd5c-7eb6-45a1-8deb-5abffbc5ae74
• Commercial Distribution Discontinuation: 2018-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ETHIBOND
• Version Model Number: X805H
• Catalog Number: X805H
• Company DUNS: 829465157
• Company Name: ETHICON, LLC
• 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(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031057968 [Primary]
GS1	30705031057962 [Package]; Contains: 10705031057968; Package: BOX [36 Units]; Discontinued: 2018-10-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K946173

FDA Product Code

• GAQ: SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-09-24

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• 10705031057838: Green Braided Nonabsorble Suture, Coated with Polybutilate
• 30705031057962: Green Braided Nonabsorble Suture, Coated with Polybutilate
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• 10705031001268: Green Braided Nonabsorble Suture, Coated with Polybutilate