Makrite Industries Inc.

GUDID 06924997807876

NIOSH approved and FDA cleared cone style N95 disposable respirator, medium and large size.

DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD.

Surgical/medical respirator, non-antimicrobial, single-use

• Primary Device ID: 06924997807876
• NIH Device Record Key: 6fdd6831-b872-4d45-bc22-b99598ed4fd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Makrite Industries Inc.
• Version Model Number: 9500-N95
• Company DUNS: 528182541
• Company Name: DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD.
• 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: true
• Manufacturing Date: true
• 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	06924997807876 [Primary]

FDA Product Code

• MSH: Respirator, 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: 2023-10-06
• Device Publish Date: 2023-09-28

On-Brand Devices [Makrite Industries Inc.]

• 06924997819114: NIOSH approved and FDA cleared cone style N95 disposable respirator, adult small size.
• 06924997809061: NIOSH approved and FDA cleared duckbill style N95 disposable respirator, regular size.
• 06924997807876: NIOSH approved and FDA cleared cone style N95 disposable respirator, medium and large size.