Edge™ EarLoop Procedure Masks” 5722009

GUDID 10818365020932

Earloop Procedure Masks, ASTM Level 1, White, Box

EDGE ENDO LLC

Surgical/medical face mask, single-use

• Primary Device ID: 10818365020932
• NIH Device Record Key: ed00300e-b6ae-485f-a03d-52d694a54aa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge™ EarLoop Procedure Masks”
• Version Model Number: 5722009
• Catalog Number: 5722009
• Company DUNS: 078474365
• Company Name: EDGE ENDO LLC
• Device Count: 50
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818365020935 [Unit of Use]
GS1	10818365020932 [Primary]
GS1	20818365020939 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• FXX: Mask, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-02-06

Devices Manufactured by EDGE ENDO LLC

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• 10818365020932 - Edge™ EarLoop Procedure Masks”: 2020-05-06Earloop Procedure Masks, ASTM Level 1, White, Box
• 10818365020932 - Edge™ EarLoop Procedure Masks”: 2020-05-06 Earloop Procedure Masks, ASTM Level 1, White, Box
• 10818365020949 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 1, Pink, Box
• 10818365020956 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 1, Blue, Box
• 10818365020963 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 2, White, Box
• 10818365020970 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 2, Pink, Box
• 10818365020987 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 2, Blue, Box
• 20818365020991 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 3, White, Box