Patterson® Earloop Mask

GUDID D6620712775650

Earloop Procedure Sensitive Mask White Level 3

PATTERSON DENTAL SUPPLY, INC.

Surgical/medical face mask, single-use

• Primary Device ID: D6620712775650
• NIH Device Record Key: 8a304095-2f99-4ac3-ac38-8fbea3d3e9b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patterson® Earloop Mask
• Version Model Number: 71277565
• Company DUNS: 171843584
• Company Name: PATTERSON DENTAL SUPPLY, INC.
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D6620712775650 [Unit of Use]
HIBCC	D6620712775652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051291

FDA Product Code

• FXX: Mask, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-03
• Device Publish Date: 2021-04-23

On-Brand Devices [Patterson® Earloop Mask]

• D6620712775650: Earloop Procedure Sensitive Mask White Level 3
• D6620712775570: Patterson Earloop Procedure Mask Teal Level 3
• D6620712775400: Patterson Earloop Procedure Mask Levender Level 3
• D6620712775320: Patterson Earloop Procedure Mask Pink Levcel 3
• D6620712775240: Patterson Earloop Procedure Mask Blue Level 3
• D6620712775080: Patterson Earloop Procedure Mask Blue Level 2
• D6620712774900: Earloop Procedure Sensitive Mask White Level 1
• D6620712774820: Patterson Earloop Procedure Mask Lavender Level 1
• D6620712774740: Patterson Earloop Procedure Mask Pink Level 1