Fluoro-Shield 0117333M

GUDID 00857164008034

Radiation Reduction Gloves, Size 8 1/2

MUNDY MEDICAL MARKETING INC

Radiation shielding glove

• Primary Device ID: 00857164008034
• NIH Device Record Key: b87c44b4-cd7d-4fae-adb2-bc3105fd11d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluoro-Shield
• Version Model Number: 011733M
• Catalog Number: 0117333M
• Company DUNS: 097037857
• Company Name: MUNDY MEDICAL MARKETING INC
• Device Count: 1
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857164008034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K893093

FDA Product Code

• LZC: Patient Examination Glove, Specialty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-13
• Device Publish Date: 2018-06-12

On-Brand Devices [Fluoro-Shield]

• 00857164008041: Radiation Reduction Gloves, Size 9
• 00857164008034: Radiation Reduction Gloves, Size 8 1/2
• 00857164008027: Radiation Reduction Gloves, Size 8
• 00857164008010: Radiation Reduction Gloves, Size 7 1/2
• 00857164008003: Radiation Reduction Gloves, Size 7