HAVEL'S B66K

GUDID B070B66K1

Havel's Incorporated

Silk suture, sterile

• Primary Device ID: B070B66K1
• NIH Device Record Key: 8a2c296e-6b65-4637-93b1-0a2efc09ec3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAVEL'S
• Version Model Number: SUT. 5-0 SILK BLK 18"/DS-18
• Catalog Number: B66K
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B070B66K0 [Primary]
HIBCC	B070B66K1 [Package]; Contains: B070B66K0; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• GAP: Suture, Nonabsorbable, Silk

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