Eta

GUDID 10852212003525

Eye Shield Earloop Mask - ASTM Level 2

PRESTIGE AMERITECH, LTD.

Surgical/medical face mask, single-use

• Primary Device ID: 10852212003525
• NIH Device Record Key: 3f13753e-3ec4-4aea-be11-0fe18cac71eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eta
• Version Model Number: 7410E2
• Company DUNS: 199692794
• Company Name: PRESTIGE AMERITECH, LTD.
• Device Count: 40
• 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

Customer Support Contacts

• Phone: 18664018972
• Email: orders@prestigeam.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852212003528 [Primary]
GS1	10852212003525 [Package]; Contains: 00852212003528; Package: Case [10 Units]; In Commercial Distribution
GS1	80852212003524 [Unit of Use]

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: 2019-09-17

On-Brand Devices [Eta]

• 10852212003525: Eye Shield Earloop Mask - ASTM Level 2
• 10852212003402: SURGICAL EARLOOP FACE MASK WITH BOTTOM GAP SHIELD