REFLECTION SKY SENSITIVE NITRILE PF EXAM 438821

GUDID D7664388212

Smarthealth, Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: D7664388212
• NIH Device Record Key: c8c8e41c-d4ea-42f6-8835-52885eddce14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFLECTION SKY SENSITIVE NITRILE PF EXAM
• Version Model Number: 438821
• Catalog Number: 438821
• Company DUNS: 061081477
• Company Name: Smarthealth, Inc.
• Device Count: 200
• 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	D7664388210 [Unit of Use]
HIBCC	D7664388211 [Primary]
HIBCC	D7664388212 [Package]; Contains: D7664388211; 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 SKY SENSITIVE NITRILE PF EXAM]

• D7664388242: 438824
• D7664388232: 438823
• D7664388222: 438822
• D7664388212: 438821