Face shield SHL-002

GUDID 00848956003016

HEALTHMARK INDUSTRIES CO., INC.

Face splash shield, single-use Face splash shield, single-use Face splash shield, single-use Face splash shield, single-use

• Primary Device ID: 00848956003016
• NIH Device Record Key: 4de595cd-7a5d-49e0-abfe-0ce98bd89fac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Face shield
• Version Model Number: SHL-002
• Catalog Number: SHL-002
• Company DUNS: 057680480
• Company Name: HEALTHMARK INDUSTRIES CO., INC.
• Device Count: 100
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848956003016 [Unit of Use]
GS1	20848956003010 [Primary]

FDA Product Code

• LYU: Accessory, Surgical Apparel

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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Face shield]

• 00848956003016: SHL-002
• 00848956003191: SHL-003
• 00848956002774: SHL-001