Firefly Global

GUDID 00851289007217

Otoscope Specula

Firefly Global

Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct

• Primary Device ID: 00851289007217
• NIH Device Record Key: 6c2c1e0a-8050-446a-a9fb-2939b3a7e00b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Firefly Global
• Version Model Number: ES2040
• Company DUNS: 020089936
• Company Name: Firefly Global
• Device Count: 1
• DM Exempt: true
• 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: false
• 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	00851289007217 [Primary]

FDA Product Code

• ERA: Otoscope

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: 2022-09-08
• Device Publish Date: 2022-08-31

On-Brand Devices [Firefly Global]

• 00851289007217: Otoscope Specula
• 00851289007231: Otoscope Specula
• 00851289007286: Otoscope Specula