N4.5C Tips PK100

GUDID 05060396172229

Probe Ear Tip, neonate, N4.5C, Yellow (pack of 100). For DPOAE and TEOAE testing. Appropriate for newborns with approx. 4.5mm (0.18") ear canal. The N4.5C probe tip is to be used with X-series probes (via Neonate Tip Holder). NB: Otodynamics probe tips are latex-free. Recommended for single use.

OTODYNAMICS LIMITED

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• Primary Device ID: 05060396172229
• NIH Device Record Key: f0da94ae-eb33-4021-8dd8-63f9796d552d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N4.5C Tips PK100
• Version Model Number: T-N4.5C
• Company DUNS: 235908050
• Company Name: OTODYNAMICS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060396172229 [Primary]

FDA Product Code

• EWO: Audiometer

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: 2023-04-10
• Device Publish Date: 2023-04-01

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