HAVEL'S A66EL

GUDID B070A66EL1

3/0 PLAIN GUT SUTURE 18" DS-18

Havel's Incorporated

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• Primary Device ID: B070A66EL1
• NIH Device Record Key: ef992995-9a6e-45e7-8f0a-d1bbf0c90ffa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAVEL'S
• Version Model Number: 3/0 PLAIN GUT 18" DS-18
• Catalog Number: A66EL
• Company DUNS: 101497568
• Company Name: Havel's Incorporated
• 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: true
• 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: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM
• Phone: 800-638-4770
• Email: RHUNLEY@HAVELS.COM

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B070A66EL0 [Primary]
HIBCC	B070A66EL1 [Package]; Contains: B070A66EL0; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896554

FDA Product Code

• GAL: Suture, Absorbable, Natural

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-16