Penguin ENT Scope model

GUDID 04711099370016

Penguin Scope is an outstanding medical innovation designed specifically for comprehensive ear examinations. This device is trusted by medical professionals around the world, and its unique design allows for deep penetration into the ear canal and examination of the eardrum, with multiple uses: Penguin Scope can help you detect potential ear infections, earwax buildup, and foreign object invasion. Penguin Scope can regularly assess ear health, which is particularly beneficial for ears that are prone to problems. Penguin Scope cleanses hearing aid equipment to provide peace of mind by maintaining performance and hygiene. Penguin Scope can provide remote medical support, provide initial assessments for professionals, and assist them in making medical treatment decisions.

OPCOM INC.

Otoscope, direct

• Primary Device ID: 04711099370016
• NIH Device Record Key: ba98e109-6592-469d-bc3d-c6ba3771cb44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Penguin ENT Scope model
• Version Model Number: CP1310F6
• Company DUNS: 657204525
• Company Name: OPCOM INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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	04711099370016 [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: 2024-12-30
• Device Publish Date: 2024-12-20

On-Brand Devices [Penguin ENT Scope model ]

• 04711099370047: Penguin Scope is an outstanding medical innovation designed specifically for comprehensive ear e
• 04711099370016: Penguin Scope is an outstanding medical innovation designed specifically for comprehensive ear e