REFLECTION POLYCHLOR PF EXAM GRN 433061

GUDID D7664330612

Smarthealth, Inc.

Polychloroprene examination/treatment glove, non-powdered

• Primary Device ID: D7664330612
• NIH Device Record Key: d7d5b7d6-248d-4ad8-90f5-92940ec0c3b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFLECTION POLYCHLOR PF EXAM GRN
• Version Model Number: 433061
• Catalog Number: 433061
• Company DUNS: 061081477
• Company Name: Smarthealth, Inc.
• Device Count: 100
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7664330610 [Unit of Use]
HIBCC	D7664330611 [Primary]
HIBCC	D7664330612 [Package]; Contains: D7664330611; Package: case [12 Units]; In Commercial Distribution

FDA Product Code

• LZA: Polymer Patient Examination Glove

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: 2022-12-06
• Device Publish Date: 2022-11-28

On-Brand Devices [ REFLECTION POLYCHLOR PF EXAM GRN]

• D7664330632: 433063
• D7664330612: 433061