FOCUS Interbody System

GUDID 00810005113656

22L x 10W x 12H x 18LA

OrthoCircle Spine

Metallic spinal interbody fusion cage

• Primary Device ID: 00810005113656
• NIH Device Record Key: 8ccadb8c-959f-403f-b8dc-7f4370386118
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOCUS Interbody System
• Version Model Number: 203.2812
• Company DUNS: 040985864
• Company Name: OrthoCircle Spine
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810005113656 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-23
• Device Publish Date: 2022-11-15

On-Brand Devices [FOCUS Interbody System]

• 00810005113670: 22L x 10W x 13H x 18LA
• 00810005113663: 22L x 10W x 11H x 18LA
• 00810005113656: 22L x 10W x 12H x 18LA
• 00810005113373: 32L x 10W x 13H x 10 LA
• 00810005113328: 27L x 10W x 13H x 18 LA
• 00810005113311: 27L x 10W x 12H x 18 LA
• 00810005113304: 27L x 10W x 11H X 18 LA
• 00810005112505: 27L x 10W x 14H x 5 LA
• 00810005112499: 27L x 10W x 13H x 5 LA
• 00810005112482: 27L x 10W x 12H x 5 LA
• 00810005112475: 27L x 10W x 11H X 5 LA
• 00810005112468: 27L x 10W x 10H x 5 LA
• 00810005112451: 27L x 10W x 9H x 5 LA
• 00810005112444: 27L x 10W x 8H x 5 LA
• 00810005112437: 27L x 10W x 7H x 5 LA