PTeye Parathyroid Detection System

GUDID 00865124000431

PTeye Console.

AiBiomed

Intraoperative parathyroid detection system control unit

• Primary Device ID: 00865124000431
• NIH Device Record Key: bf9d04fc-a595-400f-8c87-0f408fc46f3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PTeye Parathyroid Detection System
• Version Model Number: PTeye
• Company DUNS: 079623223
• Company Name: AiBiomed
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865124000431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170056

FDA Product Code

• QDF: Parathyroid Autofluorescence Detection Device

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: 2019-12-18
• Device Publish Date: 2019-12-10

Devices Manufactured by AiBiomed

• 00865124000431 - PTeye Parathyroid Detection System: 2019-12-18PTeye Console.
• 00865124000431 - PTeye Parathyroid Detection System: 2019-12-18 PTeye Console.
• 00865124000448 - PTeye Fiber Optic Probe: 2019-12-18 Fiber Optic Probe. Single Use. Sterile. 1 unit per package.