Cyber-Gel Glove PF Latex 1035123

GUDID H65810351232

Cyber-Gel Glove PF Latex X-Small

HENRY SCHEIN, INC.

Hevea-latex examination/treatment glove, non-powdered, non-sterile Hevea-latex examination/treatment glove, non-powdered, non-sterile Hevea-latex examination/treatment glove, non-powdered, non-sterile Hevea-latex examination/treatment glove, non-powdered, non-sterile

• Primary Device ID: H65810351232
• NIH Device Record Key: 0adb08c1-415e-4464-a141-13682e11ce7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cyber-Gel Glove PF Latex
• Version Model Number: 1035123
• Catalog Number: 1035123
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 100
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H65810351231 [Primary]
HIBCC	H65810351232 [Package]; Contains: H65810351231; Package: [20 Units]; In Commercial Distribution
HIBCC	H65810351239 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981917

FDA Product Code

• LYY: Latex 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: 2020-05-21
• Device Publish Date: 2020-05-13

On-Brand Devices [Cyber-Gel Glove PF Latex]

• 20814739020192: Cyber-Gel Glove PF Latex Large
• 20814739020185: Cyber-Gel Glove PF Latex Medium
• 20814739020178: Cyber-Gel Glove PF Latex Small
• 20304040101371: Cyber-Gel Glove PF Latex X-Small
• 20304040101364: Cyber-Gel Glove PF Latex X-Large
• H65810351232: Cyber-Gel Glove PF Latex X-Small