Arthrex BioExpress

GUDID 10815634020693

GD-1115-100 with 45 degree custom cannula

MICROMEDICS, INC.

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• Primary Device ID: 10815634020693
• NIH Device Record Key: d71079df-2614-4b40-ad83-b2b2b84d5b37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arthrex BioExpress
• Version Model Number: ABS-10053-10-45
• 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	00815634020696 [Primary]
GS1	10815634020693 [Package]; Contains: 00815634020696; Package: Inner Pack [5 Units]; In Commercial Distribution
GS1	20815634020690 [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