Arthrex BioExpress

GUDID 10815634020709

GD-1115-150 with 45 degree custom cannula

MICROMEDICS, INC.

Bone graft delivery kit

• Primary Device ID: 10815634020709
• NIH Device Record Key: 8da072ab-1016-43df-9276-f2837db05f36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arthrex BioExpress
• Version Model Number: ABS-10053-15-4
• Company DUNS: 066839630
• Company Name: MICROMEDICS, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815634020702 [Primary]
GS1	10815634020709 [Package]; Contains: 00815634020702; Package: Inner Pack [5 Units]; In Commercial Distribution
GS1	20815634020706 [Package]; Package: Case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151543

FDA Product Code

• FMF: Syringe, Piston

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: 2021-05-03
• Device Publish Date: 2021-04-25

On-Brand Devices [Arthrex BioExpress]

• 10815634020709: GD-1115-150 with 45 degree custom cannula
• 10815634020693: GD-1115-100 with 45 degree custom cannula
• 10815634020686: Graft Delivery Device
• 10815634020334: Graft Delivery Device