Figure 8 Sternotomy Closure Device

GUDID 00862376000325

Single Straps Packaged Assembly

FIGURE 8 SURGICAL, INC.

Sternal fixation device

• Primary Device ID: 00862376000325
• NIH Device Record Key: 5afc159d-7043-4a51-ab36-69d68a12020d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Figure 8 Sternotomy Closure Device
• Version Model Number: FP-20186
• Company DUNS: 078582803
• Company Name: FIGURE 8 SURGICAL, INC.
• 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: 304-514-3414
• Email: brianmiller32@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862376000325 [Primary]

FDA Product Code

• JDQ: Cerclage, Fixation

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: 2017-12-20

On-Brand Devices [Figure 8 Sternotomy Closure Device]

• 00862376000349: Sternotomy Closure Device (Shipper)
• 00862376000332: Double Straps Packaged Assembly
• 00862376000325: Single Straps Packaged Assembly
• 00862376000301: 20155