HAVEL'S

GUDID B070A68EL1

SUTURE 3-0 PLAIN GUT 18'/DS-24

Havel's Incorporated

Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain

• Primary Device ID: B070A68EL1
• NIH Device Record Key: 3fa310b8-7fb3-4891-8c79-d59ae5778110
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAVEL'S
• Version Model Number: SUT. 3-0 PLAIN GUT 18"/DS-24
• 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	B070A68EL0 [Primary]
HIBCC	B070A68EL1 [Package]; Contains: B070A68EL0; 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