Standard Imaging IVB 1000 Well Chamber 90009

GUDID 00866562000250

Standard Imaging IVB 1000 is a medical device intended as a transducer for brachytherapy radiation QA measurements.

STANDARD IMAGING INC.

Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter

• Primary Device ID: 00866562000250
• NIH Device Record Key: cfaca002-39a5-49c5-a2bd-0c8fac26b38c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Imaging IVB 1000 Well Chamber
• Version Model Number: 90009
• Catalog Number: 90009
• Company DUNS: 788084705
• Company Name: STANDARD IMAGING INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866562000250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001825

FDA Product Code

• KPT: Calibrator, Dose, Radionuclide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-11

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