HAVEL'S A64E

GUDID B070A64E1

SUTURE 3-0 PLAIN GUT 18"/HS-24

Havel's Incorporated

Catgut suture, plain

• Primary Device ID: B070A64E1
• NIH Device Record Key: 5717e8d1-a1b8-4270-bada-691b9b7f27ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAVEL'S
• Version Model Number: SUT 3-0 PLAIN GUT 18"/HS-24
• Catalog Number: A64E
• 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
• 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	B070A64E0 [Primary]
HIBCC	B070A64E1 [Package]; Contains: B070A64E0; 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