MITEK SPORTS MEDICINE

GUDID 20815634020003

MITEK SPORTS MEDICINE RATIO APPLICATOR ASSEMBLY 11:1

MICROMEDICS, INC.

Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe

• Primary Device ID: 20815634020003
• NIH Device Record Key: 9ab53a69-a233-467a-ac1a-1aaf6d83abd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MITEK SPORTS MEDICINE
• Version Model Number: 278011
• Company DUNS: 066839630
• Company Name: MICROMEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815634020009 [Primary]
GS1	10815634020006 [Package]; Contains: 00815634020009; Package: Inner Pack [10 Units]; In Commercial Distribution
GS1	20815634020003 [Package]; Contains: 10815634020006; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• KYZ: Syringe, Irrigating (Non Dental)

Sterilization

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

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

[20815634020003]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-18
• Device Publish Date: 2019-01-16

On-Brand Devices [MITEK SPORTS MEDICINE]

• 20815634020041: MITEK SPORTS MEDICINE DUAL CANNULA, MALLEABLE APPLICATOR TIP 20 GA X 18 CM
• 20815634020034: MITEK SPORTS MEDICINE DUAL CANNULA, MALLEABLE APPLICATOR TIP 20 GA X 10 CM
• 00815634020023: MITEK SPORTS MEDICINE DUAL CANNULA, MALLEABLE APPLICATOR TIP 20 GA X 5 CM
• 20815634020010: MITEK SPORTS MEDICINE DUAL SPRAY TIP APPLICATOR TIP
• 20815634020003: MITEK SPORTS MEDICINE RATIO APPLICATOR ASSEMBLY 11:1