Simulator Dot Reticle Set

GUDID B365548830

Aktina Corp.

Patient positioning patterned-light instrument

• Primary Device ID: B365548830
• NIH Device Record Key: 2a5e5171-8ad7-417e-8683-c7bb8b33d968
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simulator Dot Reticle Set
• Version Model Number: 54-883
• Company DUNS: 787178920
• Company Name: Aktina Corp.
• 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: false
• 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
HIBCC	B365548830 [Primary]

FDA Product Code

• IWE: Monitor, Patient Position, Light-Beam

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: 2021-05-31
• Device Publish Date: 2021-05-21

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